{ "schema_version": 1, "collection": "instruments", "generated_at": "2026-09-25", "source": "https://gxplex.com", "notice": "Reports the published status of regulatory documents. No advice or interpretation.", "source_terms": "This site compiles publicly available regulatory information. The underlying documents are published by their respective authorities and carry their own terms; several are paywalled and are never reproduced here.", "rights": { "statement": "Carried in `source_terms` on this envelope. It is the whole of what this record states on the subject.", "per_row_field": "licence_class", "per_row_field_served_at": "https://gxplex.com/api/v1/instruments.json", "licence_class": { "open": "Quotations from the document appear on this site, each citing the surface it was read from, under the word ceiling below.", "restricted": "No text from the document appears on this site. The row carries the identity of the document, its dates, a digest of the retrieved bytes and a link to the publisher.", "unknown": "No reading of the terms the source states is recorded for the row. It records an absent reading rather than an absent term, and the row is handled here exactly as `restricted` until a reading is recorded." }, "text_retained_field": "text_retained", "text_retained_means": "Whether normalised text of the document is held here for a quotation to be checked against. Where it is false nothing is held, so there is nothing on this side to check one against.", "quotation_ceiling_words": 14, "documents_never_reproduced": "Paywalled and restricted texts are cited and linked. They are never excerpted here and never diffed here." }, "schema": "https://gxplex.com/api/v1/schema/instruments.json", "lens": { "expression": "facet:value,facet:value", "carrier": { "page": "the fragment, after #lens=", "machine": "the query string, ?lens=" }, "max_terms": 2, "value_encoding": "encodeURIComponent", "facets_honoured": [ "verification", "status", "jurisdiction", "subject", "class" ], "facets_withheld": [], "population": "tracked entries", "joins_to_a_tracked_entry": false, "row_terms_describe": null, "vocabulary": { "verification": { "frozen": 34, "verified": 55, "register": 25, "awaiting": 16, "tool": 1, "absence": 1 }, "status": { "unknown": 74, "final": 39, "in-force": 13, "draft": 3, "superseded": 1, "withdrawn": 2 }, "jurisdiction": { "Brazil": 1, "International": 49, "EU": 47, "US": 27, "Canada": 1, "UK": 3, "China": 1, "Japan": 1, "Switzerland": 1, "Australia": 1 }, "subject": { "artificial intelligence": 13, "computerised systems": 5, "unstated": 66, "manufacturing": 5, "clinical": 2, "validation": 3, "medical devices": 7, "in vitro diagnostic": 1, "medical device": 8, "software": 10, "computer software": 1, "quality management": 3, "data integrity": 5, "cybersecurity": 3, "security": 11, "machine learning": 3, "electronic records": 2, "electronic signatures": 2, "risk management": 4, "health software": 1, "trustworthiness": 3, "information security": 5, "governance": 1, "data quality": 1, "good manufacturing practice": 2 }, "class": { "unstated": 81, "consensus standard": 28, "authority guidance": 12, "legal act": 7, "Regulation": 3, "Code of Federal Regulations": 1 } }, "value_labels": { "verification": { "verified": "verified", "tool": "tool-read", "awaiting": "awaiting", "absence": "checked — no status stated", "unrecorded": "check unrecorded", "frozen": "not re-checked", "register": "a register" }, "subject": { "unstated": "title states no subject" }, "class": { "unstated": "title states no class" } }, "applied": null, "not_applied_because": "This document is a static file and this deployment runs no server, so a query string reaches nothing that could filter it. An address carrying a lens returns this whole document. The vocabulary above and the facet memberships on each row are what the same lens is applied to these bytes with; a full result here is never evidence that a lens matched everything.", "variants_not_published": { "single_facet_lenses_here": 53, "two_facet_lenses": "measured per surface and recorded, with the day and the method, beside lensDeclaration in src/lib/lens.ts", "why": "One document per lens would mint a permanent address per lens. Under this record’s frame a published address is a citation that has to keep resolving, so that is a frame change rather than a build decision." } }, "rights_fields": { "fields": [ "text_retained", "licence_class", "quote_allowed", "snapshot_available" ], "rows": 132, "rows_with_a_reading": 132, "rows_without_a_reading": 0, "rows_naming_an_unheld_id": 0, "rows_naming_no_entry": 0, "licence_class": { "open": 99, "restricted": 33, "unknown": 0 }, "quote_allowed_true": 99, "quote_allowed_false": 33, "text_retained_true": 126, "snapshot_available_true": 126, "retained_here_but_not_quoted_here": 32, "snapshot_without_prose": 0, "nulls_mean_unheld_id": "This id resolves to no tracked entry, so no terms reading, no retention measurement and no snapshot measurement exists for it. Four nulls record the absence of a reading, never a reading that came back negative.", "nulls_mean_no_entry": "This object names no tracked entry, so no terms reading was looked for. Four nulls record that no lookup applies here, which is a different fact from a lookup that found nothing." }, "order": "items are sorted by `id`, ascending, byte order", "rights_population": { "field": "licence_class", "of": 132, "counts": { "open": 99, "restricted": 33, "unknown": 0 }, "text_retained_true": 126, "text_retained_false": 6, "unknown_means": "No reading of the terms the source states is recorded for the row. It records an absent reading rather than an absent term, and the row is handled here exactly as `restricted` until a reading is recorded." }, "count": 132, "items": [ { "id": "anvisa-ai", "title": "ANVISA positions on computerised systems and artificial intelligence", "short_title": "ANVISA", "authority": "Agência Nacional de Vigilância Sanitária", "jurisdiction": "Brazil", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.gov.br/anvisa/pt-br/assuntos/regulamentacao", "secondary_urls": [], "topics": [ "artificial intelligence", "computerised systems" ], "summary": "Brazilian health regulatory agency publications addressing computerised systems and artificial intelligence.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 40, "band": "30-90", "first_observed": "2026-08-17" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": false, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "Brazil" ], "subject": [ "artificial intelligence", "computerised systems" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/anvisa-ai", "quote_allowed": true, "snapshot_available": false, "rights_of": "anvisa-ai" }, { "id": "astm-e2363", "title": "ASTM E2363 — Terminology relating to process analytical technology", "short_title": "ASTM E2363", "authority": "ASTM International", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2023-02-23", "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://store.astm.org/e2363-23.html", "secondary_urls": [], "topics": [], "summary": "Standard terminology relating to process analytical technology in the pharmaceutical industry.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 59, "band": "30-90", "first_observed": "2026-07-29" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/astm-e2363", "quote_allowed": false, "snapshot_available": true, "rights_of": "astm-e2363" }, { "id": "astm-e2500", "title": "ASTM E2500 — Specification, design and verification of manufacturing systems", "short_title": "ASTM E2500", "authority": "ASTM International", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2025-04-01", "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://store.astm.org/e2500-25.html", "secondary_urls": [], "topics": [ "manufacturing" ], "summary": "Standard guide for the specification, design and verification of pharmaceutical and biopharmaceutical manufacturing systems and equipment.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 59, "band": "30-90", "first_observed": "2026-07-29" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "manufacturing" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/astm-e2500", "quote_allowed": false, "snapshot_available": true, "rights_of": "astm-e2500" }, { "id": "astm-e2537", "title": "ASTM E2537 — Continuous quality verification", "short_title": "ASTM E2537", "authority": "ASTM International", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": "2024-10-30", "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.astm.org/e2537-16.html", "secondary_urls": [], "topics": [], "summary": "Standard guide for the application of continuous quality verification to pharmaceutical and biopharmaceutical manufacturing.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/astm-e2537", "quote_allowed": false, "snapshot_available": true, "rights_of": "astm-e2537" }, { "id": "cen-jtc21-programme", "title": "CEN/CENELEC JTC 21 work programme", "short_title": "CEN/CLC JTC 21", "authority": "CEN/CENELEC", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/", "secondary_urls": [], "topics": [], "summary": "Published work programme of the CEN/CENELEC technical committee developing European standards in support of the EU AI Act.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/cen-jtc21-programme", "quote_allowed": true, "snapshot_available": true, "rights_of": "cen-jtc21-programme" }, { "id": "cisa-cpg", "title": "CISA Cross-Sector Cybersecurity Performance Goals (CPG Report 2.0)", "short_title": "CISA CPG 2.0", "authority": "Cybersecurity and Infrastructure Security Agency", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cisa.gov/sites/default/files/2025-12/CPG_Report_2.0_508c.pdf", "secondary_urls": [], "topics": [], "summary": "Document published by Cybersecurity and Infrastructure Security Agency, sourced by the publisher's own page as read on 2026-08-12.", "watch_cadence": "monthly", "first_observed": "2026-08-12", "observation_maturity": { "days": 45, "band": "30-90", "first_observed": "2026-08-12" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from a text/plain robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/cisa-cpg", "quote_allowed": true, "snapshot_available": true, "rights_of": "cisa-cpg" }, { "id": "ema-ai-reflection", "title": "EMA reflection paper on the use of artificial intelligence in the medicinal product lifecycle", "short_title": "EMA AI reflection paper", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "final", "status_qualifier": null, "status_as_of": "2023-11-21", "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/use-artificial-intelligence-ai-medicinal-product-lifecycle-scientific-guideline", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "EMA reflection paper addressing the use of artificial intelligence across the medicinal product lifecycle.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "EU" ], "subject": [ "artificial intelligence" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ema-ai-reflection", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-ai-reflection" }, { "id": "ema-annex11-concept-paper", "title": "EMA concept paper on the revision of Annex 11", "short_title": "Annex 11 concept paper", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/concept-paper-revision-annex-11-guidelines-good-manufacturing-practice-medicinal-products-computerised-systems_en.pdf", "secondary_urls": [], "topics": [], "summary": "The concept paper that initiated the current revision of EU GMP Annex 11, setting out the scope of the intended changes.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/ema-annex11-concept-paper", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-annex11-concept-paper" }, { "id": "ema-ct-computerised-systems", "title": "EMA guideline on computerised systems and electronic data in clinical trials", "short_title": "EMA CT computerised systems", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/guideline-computerised-systems-and-electronic-data-clinical-trials_en.pdf", "secondary_urls": [], "topics": [ "computerised systems", "clinical" ], "summary": "Guideline addressing computerised systems and electronic data in clinical trials, covering validation, data integrity, security and cloud-based solutions.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "EU" ], "subject": [ "computerised systems", "clinical" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ema-ct-computerised-systems", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-ct-computerised-systems" }, { "id": "ema-data-quality-framework", "title": "Data Quality Framework for EU medicines regulation", "short_title": "EMA data quality framework", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "final", "status_qualifier": null, "status_as_of": "2023-10-30", "last_verified": "2026-08-05", "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/data-quality-framework-eu-medicines-regulation_en.pdf", "secondary_urls": [], "topics": [], "summary": "EMA guideline setting out a data quality framework for EU medicines regulation.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-05", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ema-data-quality-framework", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-data-quality-framework" }, { "id": "ema-pics-annex15-concept", "title": "EMA and PIC/S concept paper on the revision of GMP Annex 15", "short_title": "Annex 15 revision concept paper", "authority": "European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/scientific-guideline/concept-paper-revision-guidelines-good-manufacturing-practice-medicinal-products-annex-15-qualification-validation-corrigendum_en.pdf", "secondary_urls": [], "topics": [], "summary": "Joint concept paper published in January 2026 setting out the intended revision of GMP Annex 15, including extension of its scope to active substance manufacturers.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/ema-pics-annex15-concept", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-pics-annex15-concept" }, { "id": "ema-pics-data-integrity-concept", "title": "EMA and PIC/S concept paper on the revision of GMP guidance on data management and integrity", "short_title": "DI revision concept paper", "authority": "European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/human-regulatory-overview/research-and-development/compliance-research-and-development/good-manufacturing-practice", "secondary_urls": [], "topics": [], "summary": "Joint concept paper opened for consultation in February 2026 setting out the intended revision of GMP guidance on data management and integrity, the framework currently carried by PIC/S PI 041.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ema-pics-data-integrity-concept", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-pics-data-integrity-concept" }, { "id": "ema-work-programme", "title": "EMA work programme and planning documents", "short_title": "EMA work programme", "authority": "European Medicines Agency", "jurisdiction": "EU", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/about-us/annual-reports-work-programmes", "secondary_urls": [], "topics": [], "summary": "EMA planning and reporting documents setting out the agency's programme of work for the period.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ema-work-programme", "quote_allowed": true, "snapshot_available": true, "rights_of": "ema-work-programme" }, { "id": "eu-ai-act", "title": "Regulation (EU) 2024/1689 — Artificial Intelligence Act", "short_title": "EU AI Act", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-28", "last_changed": null, "effective_date": "2028-08-02", "source_url": "https://eur-lex.europa.eu/eli/reg/2024/1689/oj", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "Regulation establishing harmonised rules on artificial intelligence, including obligations for high-risk AI systems, applied on a phased timetable.", "watch_cadence": "weekly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "artificial intelligence" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/eu-ai-act", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-ai-act" }, { "id": "eu-cyber-resilience-act", "title": "Regulation (EU) 2024/2847 — Cyber Resilience Act", "short_title": "EU Cyber Resilience Act", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2024/2847/oj", "secondary_urls": [], "topics": [], "summary": "Regulation on horizontal cybersecurity requirements for products with digital elements, including manufacturer obligations on vulnerability handling and incident reporting.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/eu-cyber-resilience-act", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-cyber-resilience-act" }, { "id": "eu-cybersecurity-act", "title": "Regulation (EU) 2019/881 — Cybersecurity Act", "short_title": "EU Cybersecurity Act", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-05", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2019/881/oj", "secondary_urls": [], "topics": [], "summary": "EU regulation on ENISA and on information and communications technology cybersecurity certification.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-05", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "Regulation" ] }, "url": "https://gxplex.com/r/eu-cybersecurity-act", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-cybersecurity-act" }, { "id": "eu-digital-omnibus-ai", "title": "Regulation (EU) 2026/1744 — Digital Omnibus on AI", "short_title": "Regulation (EU) 2026/1744", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": "2024-08-01", "last_verified": "2026-08-04", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2026/1744/oj", "secondary_urls": [], "topics": [], "summary": "Regulation amending Regulations (EU) 2024/1689, (EU) 2018/1139 and (EU) 2023/1230 as regards the simplification of the implementation of harmonised rules on artificial intelligence.", "watch_cadence": "weekly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-04", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "Regulation" ] }, "url": "https://gxplex.com/r/eu-digital-omnibus-ai", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-digital-omnibus-ai" }, { "id": "eu-gmp-annex-1", "title": "EudraLex Volume 4, Annex 1 — Manufacture of Sterile Medicinal Products", "short_title": "EU GMP Annex 1", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/e05af55b-38e9-42bf-8495-194bbf0b9262_en?filename=20220825_gmp-an1_en_0.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 1 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Sterile Medicinal Products\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-1", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-1" }, { "id": "eu-gmp-annex-10", "title": "EudraLex Volume 4, Annex 10 — Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation", "short_title": "EU GMP Annex 10", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/2a19f8d5-cc25-44ea-9296-d38e3a6c278c_en?filename=anx10_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 10 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Pressurised Metered Dose Aerosol Preparations for Inhalation\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-10", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-10" }, { "id": "eu-gmp-annex-11", "title": "EudraLex Volume 4, Annex 11 — Computerised Systems", "short_title": "EU GMP Annex 11", "authority": "European Commission", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/medicinal-products/eudralex/eudralex-volume-4_en", "secondary_urls": [], "topics": [ "computerised systems" ], "summary": "Annex to the EU GMP guide addressing computerised systems used in regulated manufacturing. A revision has been under public consultation.", "watch_cadence": "weekly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "computerised systems" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-11", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-11" }, { "id": "eu-gmp-annex-11-draft", "title": "EudraLex Volume 4, Annex 11 — Computerised Systems (consultation draft)", "short_title": "EU GMP Annex 11 (draft)", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/40231f18-e564-4043-94de-c031f813d38b_en?filename=mp_vol4_chap4_annex11_consultation_guideline_en.pdf", "secondary_urls": [], "topics": [], "summary": "Consultation draft revising the GMP annex on computerised systems, published in the EudraLex Volume 4 consultation package alongside a revised Chapter 4 and a new Annex 22.", "watch_cadence": "weekly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-11-draft", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-11-draft" }, { "id": "eu-gmp-annex-12", "title": "EudraLex Volume 4, Annex 12 — Use of Ionising Radiation in the Manufacture of Medicinal Products", "short_title": "EU GMP Annex 12", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/363e435b-23cf-4cb3-9c74-322addb81340_en?filename=anx12_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 12 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Use of Ionising Radiation in the Manufacture of Medicinal Products\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-12", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-12" }, { "id": "eu-gmp-annex-13", "title": "EudraLex Volume 4, Annex 13 — Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014", "short_title": "EU GMP Annex 13", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/a0b206a0-5788-406b-9e20-e0525b16e712_en?filename=guideline_adopted_1_en_act_part1_v3.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 13 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Detailed Commission guideline of 8 December 2017 on the good manufacturing practice for investigational medicinal products pursuant to the second paragraph of the Article 63(1) of Regulation (EU) No 536/2014\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-13", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-13" }, { "id": "eu-gmp-annex-14", "title": "EudraLex Volume 4, Annex 14 — Manufacture of Products derived from Human Blood or Human Plasma", "short_title": "EU GMP Annex 14", "authority": "European Commission", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-24", "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/a28a88b2-d510-40c6-a40d-c1989819e13e_en?filename=annex14_rev30-03_2011_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 14 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Products derived from Human Blood or Human Plasma\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-24", "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-14", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-14" }, { "id": "eu-gmp-annex-15", "title": "EudraLex Volume 4, Annex 15 — Qualification and Validation", "short_title": "EU GMP Annex 15", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": "2015-03-30", "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/7c6c5b3c-4902-46ea-b7ab-7608682fb68d_en?filename=2015-10_annex15.pdf", "secondary_urls": [], "topics": [ "validation" ], "summary": "Annex 15 to EudraLex Volume 4. The European Commission publishes it as \"Qualification and Validation\".", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "validation" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-15", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-15" }, { "id": "eu-gmp-annex-16", "title": "EudraLex Volume 4, Annex 16 — Certification by a Qualified Person and Batch Release", "short_title": "EU GMP Annex 16", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/20c41532-33d5-4635-ae80-8735d3d09fe0_en?filename=v4_an16_201510_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 16 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Certification by a Qualified Person and Batch Release\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-16", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-16" }, { "id": "eu-gmp-annex-17", "title": "EudraLex Volume 4, Annex 17 — Real Time Release Testing and Parametric release", "short_title": "EU GMP Annex 17", "authority": "European Commission", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/78d31fc9-760f-4fe9-9ccd-95595ef48a71_en?filename=2018_annex17_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 17 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Real Time Release Testing and Parametric release\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": 1, "checked_by": "machine", "check_date": "2026-08-15", "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-17", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-17" }, { "id": "eu-gmp-annex-19", "title": "EudraLex Volume 4, Annex 19 — Reference and Retention Samples", "short_title": "EU GMP Annex 19", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/b9b0cf46-07a6-4243-b801-446ccfcd2d72_en?filename=2005_12_14_annex19_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 19 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Reference and Retention Samples\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-19", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-19" }, { "id": "eu-gmp-annex-2", "title": "EudraLex Volume 4, Annex 2 — Manufacture of Biological active substances and Medicinal Products for Human Use", "short_title": "EU GMP Annex 2", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/380fdf24-8a1e-4f65-809b-e08d990d5f9e_en?filename=2018_annex2_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 2 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Biological active substances and Medicinal Products for Human Use\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-2", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-2" }, { "id": "eu-gmp-annex-21", "title": "EudraLex Volume 4, Annex 21 — Importation of medicinal products", "short_title": "EU GMP Annex 21", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/e2ddfe65-7b4e-4765-b71b-4681772d2949_en", "secondary_urls": [], "topics": [], "summary": "Annex 21 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Importation of medicinal products\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-21", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-21" }, { "id": "eu-gmp-annex-22", "title": "EudraLex Volume 4, Annex 22 — Artificial Intelligence", "short_title": "EU GMP Annex 22", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/5f38a92d-bb8e-4264-8898-ea076e926db6_en?filename=mp_vol4_chap4_annex22_consultation_guideline_en.pdf", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "Proposed GMP annex addressing the use of artificial intelligence in regulated manufacturing operations.", "watch_cadence": "weekly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "artificial intelligence" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-22", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-22" }, { "id": "eu-gmp-annex-3", "title": "EudraLex Volume 4, Annex 3 — Manufacture of Radiopharmaceuticals", "short_title": "EU GMP Annex 3", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/bf281e1f-4897-469a-ba60-18d867b14a94_en?filename=2008_09_annex3_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 3 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Radiopharmaceuticals\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-3", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-3" }, { "id": "eu-gmp-annex-6", "title": "EudraLex Volume 4, Annex 6 — Manufacture of Medicinal Gases", "short_title": "EU GMP Annex 6", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/b9dfcd18-73d2-45f8-a3a7-e4558fdc2d58_en?filename=2009_07_annex6.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 6 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Medicinal Gases\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-6", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-6" }, { "id": "eu-gmp-annex-7", "title": "EudraLex Volume 4, Annex 7 — Manufacture of Herbal Medicinal Products", "short_title": "EU GMP Annex 7", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/fd318dd6-2404-4e67-82b0-2324825e4d90_en?filename=vol4_an7_2008_09_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 7 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Herbal Medicinal Products\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-7", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-7" }, { "id": "eu-gmp-annex-8", "title": "EudraLex Volume 4, Annex 8 — Sampling of Starting and Packaging Materials", "short_title": "EU GMP Annex 8", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/22d03c04-8512-4336-89dd-556771fca388_en?filename=anx08_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 8 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Sampling of Starting and Packaging Materials\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-8", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-8" }, { "id": "eu-gmp-annex-9", "title": "EudraLex Volume 4, Annex 9 — Manufacture of Liquids, Creams and Ointments", "short_title": "EU GMP Annex 9", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/3db7d485-61e2-4f61-a16a-82a6dbf0e914_en?filename=anx09_en.pdf", "secondary_urls": [], "topics": [], "summary": "Annex 9 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Manufacture of Liquids, Creams and Ointments\".", "watch_cadence": "monthly", "first_observed": "2026-08-15", "observation_maturity": { "days": 42, "band": "30-90", "first_observed": "2026-08-15" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "allowed (parsed from health.ec.europa.eu robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-annex-9", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-annex-9" }, { "id": "eu-gmp-chapter-1", "title": "EudraLex Volume 4, Chapter 1 — Pharmaceutical Quality System", "short_title": "EU GMP Chapter 1", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/e458c423-f564-4171-b344-030a461c567f_en?filename=vol4-chap1_2013-01_en.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 1 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Pharmaceutical Quality System\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-1", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-1" }, { "id": "eu-gmp-chapter-2", "title": "EudraLex Volume 4, Chapter 2 — Personnel", "short_title": "EU GMP Chapter 2", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/11f4f8e6-a6e9-4897-afe3-f21e1dc56cb8_en?filename=2014-03_chapter_2.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 2 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Personnel\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-2", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-2" }, { "id": "eu-gmp-chapter-3", "title": "EudraLex Volume 4, Chapter 3 — Premise and Equipment", "short_title": "EU GMP Chapter 3", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/18d76565-137b-41d2-a602-794527f708c1_en?filename=chapter_3.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 3 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Premise and Equipment\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-3", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-3" }, { "id": "eu-gmp-chapter-4", "title": "EudraLex Volume 4, Chapter 4 — Documentation", "short_title": "EU GMP Chapter 4", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/104b3eb8-81a7-4858-9419-cb06562adb66_en?filename=chapter4_01-2011_en.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter of the EU GMP guide governing documentation and records, including provisions bearing on records held in computerised systems.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-4", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-4" }, { "id": "eu-gmp-chapter-4-draft", "title": "EudraLex Volume 4, Chapter 4 — Documentation (consultation draft)", "short_title": "EU GMP Chapter 4 (draft)", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/fa336a6e-753b-46fc-b53b-9178bacd8878_en?filename=mp_vol4_chap4_consultation_guideline_en.pdf", "secondary_urls": [], "topics": [], "summary": "Consultation draft revising the GMP chapter on documentation, published in the same EudraLex Volume 4 consultation package as the revised Annex 11 and the new Annex 22.", "watch_cadence": "weekly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-4-draft", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-4-draft" }, { "id": "eu-gmp-chapter-5", "title": "EudraLex Volume 4, Chapter 5 — Production", "short_title": "EU GMP Chapter 5", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/4a1fdb4f-6f6f-49c4-b264-8056e5bbe078_en?filename=chapter_5.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 5 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Production\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-5", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-5" }, { "id": "eu-gmp-chapter-6", "title": "EudraLex Volume 4, Chapter 6 — Quality Control", "short_title": "EU GMP Chapter 6", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/c74c8720-27bf-4252-808f-d65a206a90bb_en?filename=2014-11_vol4_chapter_6.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 6 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Quality Control\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-6", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-6" }, { "id": "eu-gmp-chapter-7", "title": "EudraLex Volume 4, Chapter 7 — Outsourced activities", "short_title": "EU GMP Chapter 7", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/58b5106a-cf6f-4352-9dca-1caf5d27d97e_en?filename=vol4-chap7_2012-06_en.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 7 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Outsourced activities\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-7", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-7" }, { "id": "eu-gmp-chapter-8", "title": "EudraLex Volume 4, Chapter 8 — Complaints and Product Recall", "short_title": "EU GMP Chapter 8", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/b1eb2292-cb0d-4e3f-aea9-e3fe79faf6e3_en?filename=2014-08_gmp_chap8.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 8 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Complaints and Product Recall\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-8", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-8" }, { "id": "eu-gmp-chapter-9", "title": "EudraLex Volume 4, Chapter 9 — Self Inspection", "short_title": "EU GMP Chapter 9", "authority": "European Commission", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://health.ec.europa.eu/document/download/07195808-d02e-4d7a-b8f4-f84a83278b62_en?filename=cap9_en.pdf", "secondary_urls": [], "topics": [], "summary": "Chapter 9 of the EU GMP guide, titled by the Commission's EudraLex Volume 4 index as \"Self Inspection\".", "watch_cadence": "monthly", "first_observed": "2026-08-11", "observation_maturity": { "days": 46, "band": "30-90", "first_observed": "2026-08-11" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/eu-gmp-chapter-9", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-gmp-chapter-9" }, { "id": "eu-ivdr", "title": "Regulation (EU) 2017/746 on in vitro diagnostic medical devices", "short_title": "EU IVDR", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": "2022-02-25", "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2017/746/oj", "secondary_urls": [], "topics": [ "medical devices", "in vitro diagnostic" ], "summary": "EU regulation on in vitro diagnostic medical devices.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "medical devices", "in vitro diagnostic", "medical device" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/eu-ivdr", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-ivdr" }, { "id": "eu-machinery-regulation", "title": "Regulation (EU) 2023/1230 on machinery", "short_title": "EU Machinery Regulation", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-04", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2023/1230/oj", "secondary_urls": [], "topics": [], "summary": "EU regulation on machinery, replacing Directive 2006/42/EC. Named in the title of Regulation (EU) 2026/1744 as one of the acts that regulation amends.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-04", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "Regulation" ] }, "url": "https://gxplex.com/r/eu-machinery-regulation", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-machinery-regulation" }, { "id": "eu-mdr", "title": "Regulation (EU) 2017/745 on medical devices", "short_title": "EU MDR", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": "2020-05-26", "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/reg/2017/745/oj", "secondary_urls": [], "topics": [ "medical devices" ], "summary": "A legal act of the European Parliament and Council, published as \"Regulation (EU) 2017/745 on medical devices\".", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "medical devices", "medical device" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/eu-mdr", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-mdr" }, { "id": "eu-nis2", "title": "Directive (EU) 2022/2555 — NIS2", "short_title": "EU NIS2 Directive", "authority": "European Parliament and Council", "jurisdiction": "EU", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://eur-lex.europa.eu/eli/dir/2022/2555/oj", "secondary_urls": [], "topics": [], "summary": "Directive on measures for a high common level of cybersecurity across the Union. Classifies manufacturers of basic pharmaceutical products, medical devices and in vitro diagnostics among essential entities.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/eu-nis2", "quote_allowed": true, "snapshot_available": true, "rights_of": "eu-nis2" }, { "id": "fda-ai-guidance", "title": "Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products", "short_title": "FDA AI guidance", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "draft", "status_qualifier": "recorded as draft against the primary source", "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "FDA draft guidance describing a risk-based credibility assessment framework for AI models used to support regulatory decision-making.", "watch_cadence": "weekly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 3, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "draft" ], "jurisdiction": [ "US" ], "subject": [ "artificial intelligence" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-ai-guidance", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-ai-guidance" }, { "id": "fda-aiml-device-list", "title": "FDA list of AI-enabled medical devices with marketing authorisation", "short_title": "FDA AI device list", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/medical-devices/software-medical-device-samd/artificial-intelligence-enabled-medical-devices", "secondary_urls": [], "topics": [ "medical devices" ], "summary": "A dated and periodically extended list of artificial-intelligence-enabled medical devices that have received FDA marketing authorisation.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "medical devices", "medical device" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-aiml-device-list", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-aiml-device-list" }, { "id": "fda-cdrh-aiml", "title": "Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations", "short_title": "FDA CDRH AI/ML", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "draft", "status_qualifier": "recorded as draft against the primary source", "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/artificial-intelligence-enabled-device-software-functions-lifecycle-management-and-marketing", "secondary_urls": [], "topics": [ "artificial intelligence", "software" ], "summary": "FDA guidance addressing artificial-intelligence-enabled device software functions and predetermined change control plans.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 58, "band": "30-90", "first_observed": "2026-07-30" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "draft" ], "jurisdiction": [ "US" ], "subject": [ "artificial intelligence", "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-cdrh-aiml", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-cdrh-aiml" }, { "id": "fda-clinical-decision-support", "title": "Clinical Decision Support Software", "short_title": "FDA clinical decision support", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-05", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/clinical-decision-support-software", "secondary_urls": [], "topics": [], "summary": "FDA guidance on clinical decision support software.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-05", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-clinical-decision-support", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-clinical-decision-support" }, { "id": "fda-csa", "title": "Computer Software Assurance for Production and Quality Management System Software", "short_title": "FDA CSA", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/computer-software-assurance-production-and-quality-management-system-software", "secondary_urls": [], "topics": [ "computer software", "quality management", "software" ], "summary": "FDA guidance addressing assurance activities for computer software used in production and quality systems.", "watch_cadence": "weekly", "first_observed": "2026-07-28", "observation_maturity": { "days": 58, "band": "30-90", "first_observed": "2026-07-30" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "software", "computer software", "quality management" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-csa", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-csa" }, { "id": "fda-data-integrity", "title": "Data Integrity and Compliance With Drug CGMP — Questions and Answers", "short_title": "FDA data integrity", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/data-integrity-and-compliance-drug-cgmp-questions-and-answers", "secondary_urls": [], "topics": [ "data integrity" ], "summary": "FDA guidance in question-and-answer form addressing data integrity expectations under the drug CGMP regulations.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "data integrity" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-data-integrity", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-data-integrity" }, { "id": "fda-device-cybersecurity", "title": "Cybersecurity in Medical Devices — Quality System Considerations and Content of Premarket Submissions", "short_title": "FDA device cybersecurity", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "superseded", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/cybersecurity-medical-devices-quality-system-considerations-and-content-premarket-submissions", "secondary_urls": [], "topics": [ "cybersecurity", "medical devices" ], "summary": "FDA guidance on cybersecurity expectations for medical devices, covering quality system considerations and the content of premarket submissions.", "watch_cadence": "monthly", "first_observed": "2026-08-08", "observation_maturity": null, "corroboration_count": 1, "checked_by": "machine", "check_date": "2026-09-07", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "tool" ], "status": [ "superseded" ], "jurisdiction": [ "US" ], "subject": [ "medical devices", "cybersecurity", "medical device", "security" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-device-cybersecurity", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-device-cybersecurity" }, { "id": "fda-device-cybersecurity-2026", "title": "Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions", "short_title": "FDA device cybersecurity (2026)", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/media/119933/download", "secondary_urls": [], "topics": [ "cybersecurity" ], "summary": "FDA guidance on cybersecurity for medical devices, covering quality management system considerations and the content of premarket submissions. Issued February 2026 under docket FDA-2021-D-1158.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "cybersecurity", "security" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-device-cybersecurity-2026", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-device-cybersecurity-2026" }, { "id": "fda-electronic-systems-clinical", "title": "Electronic Systems, Electronic Records, and Electronic Signatures in Clinical Investigations", "short_title": "FDA electronic systems (clinical)", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/media/166215/download", "secondary_urls": [], "topics": [], "summary": "FDA questions-and-answers guidance on electronic systems, electronic records and electronic signatures used in clinical investigations.", "watch_cadence": "monthly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-electronic-systems-clinical", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-electronic-systems-clinical" }, { "id": "fda-ema-good-ai-practice", "title": "Guiding Principles of Good AI Practice in Drug Development", "short_title": "FDA/EMA AI principles", "authority": "US Food and Drug Administration and European Medicines Agency", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ema.europa.eu/en/documents/other/guiding-principles-good-ai-practice-drug-development_en.pdf", "secondary_urls": [ "https://www.fda.gov/media/189581/download" ], "topics": [], "summary": "Ten principles jointly issued by the FDA and EMA addressing the use of artificial intelligence across the product lifecycle, including manufacturing.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-ema-good-ai-practice", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-ema-good-ai-practice" }, { "id": "fda-etp", "title": "FDA Emerging Technology Program", "short_title": "FDA ETP", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cder/emerging-technology-program", "secondary_urls": [], "topics": [], "summary": "CDER programme through which companies may discuss novel technology with the agency ahead of a regulatory submission.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-etp", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-etp" }, { "id": "fda-gmlp", "title": "Good Machine Learning Practice for Medical Device Development: Guiding Principles", "short_title": "FDA GMLP guiding principles", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/medical-devices/software-medical-device-samd/good-machine-learning-practice-medical-device-development-guiding-principles", "secondary_urls": [], "topics": [ "machine learning", "medical device" ], "summary": "Guiding principles published by FDA with Health Canada and the MHRA. Admitted from the publisher's own member listing; no status has been read and none is pre-filled.", "watch_cadence": "monthly", "first_observed": "2026-08-22", "observation_maturity": { "days": 35, "band": "30-90", "first_observed": "2026-08-22" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "machine learning", "medical device" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-gmlp", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-gmlp" }, { "id": "fda-guidance-agenda", "title": "FDA CDER Guidance Agenda", "short_title": "FDA guidance agenda", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/drugs/guidances-drugs/cder-guidance-agenda", "secondary_urls": [], "topics": [], "summary": "Annual list of new and revised draft guidances CDER plans to publish during the calendar year.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/fda-guidance-agenda", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-guidance-agenda" }, { "id": "fda-part-11-scope", "title": "Part 11, Electronic Records; Electronic Signatures — Scope and Application", "short_title": "FDA Part 11 scope", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/part-11-electronic-records-electronic-signatures-scope-and-application", "secondary_urls": [], "topics": [ "electronic records", "electronic signatures" ], "summary": "FDA guidance describing how the agency intends to interpret and enforce 21 CFR Part 11. A separate document from the rule text.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "electronic records", "electronic signatures" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-part-11-scope", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-part-11-scope" }, { "id": "fda-pccp", "title": "Marketing Submission Recommendations for a Predetermined Change Control Plan for AI-Enabled Device Software Functions", "short_title": "FDA PCCP", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/marketing-submission-recommendations-predetermined-change-control-plan-artificial-intelligence", "secondary_urls": [], "topics": [ "software" ], "summary": "FDA guidance on predetermined change control plans for artificial-intelligence-enabled device software functions.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-pccp", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-pccp" }, { "id": "fda-postmarket-cybersecurity", "title": "Postmarket Management of Cybersecurity in Medical Devices", "short_title": "FDA postmarket cybersecurity", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-05", "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/postmarket-management-cybersecurity-medical-devices", "secondary_urls": [], "topics": [], "summary": "FDA guidance addressing the postmarket management of cybersecurity in medical devices. The premarket counterpart is tracked separately.", "watch_cadence": "monthly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-05", "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-postmarket-cybersecurity", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-postmarket-cybersecurity" }, { "id": "fda-process-analytical-framework", "title": "PAT — A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance", "short_title": "FDA process analytical framework", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/pat-framework-innovative-pharmaceutical-development-manufacturing-and-quality-assurance", "secondary_urls": [], "topics": [ "manufacturing" ], "summary": "FDA guidance describing a framework for process analytical technology, including how process data may support real-time release testing.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "manufacturing" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-process-analytical-framework", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-process-analytical-framework" }, { "id": "fda-software-validation", "title": "General Principles of Software Validation", "short_title": "FDA software validation", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": "1997-06-09", "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-principles-software-validation", "secondary_urls": [], "topics": [ "validation", "software" ], "summary": "FDA guidance on validation of software used in medical devices and in the production of regulated products. Predates Computer Software Assurance and remains extant.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "validation", "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/fda-software-validation", "quote_allowed": true, "snapshot_available": true, "rights_of": "fda-software-validation" }, { "id": "health-canada-ml", "title": "Health Canada guidance on machine learning medical devices", "short_title": "Health Canada ML", "authority": "Health Canada", "jurisdiction": "Canada", "status": "draft", "status_qualifier": "under consultation", "status_as_of": "2025-02-20", "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medical-devices.html", "secondary_urls": [], "topics": [ "machine learning", "medical devices" ], "summary": "Health Canada guidance addressing machine-learning-enabled medical devices.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "draft" ], "jurisdiction": [ "Canada" ], "subject": [ "medical devices", "machine learning", "medical device" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/health-canada-ml", "quote_allowed": true, "snapshot_available": true, "rights_of": "health-canada-ml" }, { "id": "ich-e6r3", "title": "ICH E6(R3) — Good Clinical Practice", "short_title": "ICH E6(R3)", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": "2022-02-21", "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/efficacy-guidelines", "secondary_urls": [], "topics": [ "clinical" ], "summary": "ICH guideline on good clinical practice, revised to address data governance and computerised systems in trials.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": false, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "clinical" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-e6r3", "quote_allowed": true, "snapshot_available": false, "rights_of": "ich-e6r3" }, { "id": "ich-q12", "title": "ICH Q12 — Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management", "short_title": "ICH Q12", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/quality-guidelines", "secondary_urls": [], "topics": [], "summary": "ICH guideline introducing established conditions and post-approval change management protocols for lifecycle management.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-q12", "quote_allowed": true, "snapshot_available": true, "rights_of": "ich-q12" }, { "id": "ich-q13", "title": "ICH Q13 — Continuous Manufacturing of Drug Substances and Drug Products", "short_title": "ICH Q13", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/quality-guidelines", "secondary_urls": [], "topics": [ "manufacturing" ], "summary": "ICH guideline addressing scientific and regulatory considerations for continuous manufacturing.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "manufacturing" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-q13", "quote_allowed": true, "snapshot_available": true, "rights_of": "ich-q13" }, { "id": "ich-q14", "title": "ICH Q14 — Analytical Procedure Development", "short_title": "ICH Q14", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/quality-guidelines", "secondary_urls": [], "topics": [], "summary": "ICH guideline on the development of analytical procedures, adopted alongside the ICH Q2(R2) revision.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-q14", "quote_allowed": true, "snapshot_available": true, "rights_of": "ich-q14" }, { "id": "ich-q2r2", "title": "ICH Q2(R2) — Validation of Analytical Procedures", "short_title": "ICH Q2(R2)", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/quality-guidelines", "secondary_urls": [], "topics": [ "validation" ], "summary": "ICH guideline on the validation of analytical procedures, revised alongside ICH Q14.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "validation" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-q2r2", "quote_allowed": true, "snapshot_available": true, "rights_of": "ich-q2r2" }, { "id": "ich-q9r1", "title": "ICH Q9(R1) — Quality Risk Management", "short_title": "ICH Q9(R1)", "authority": "International Council for Harmonisation", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://ich.org/page/quality-guidelines", "secondary_urls": [], "topics": [ "risk management" ], "summary": "ICH guideline on quality risk management, revised to address subjectivity, formality and risk-based decision-making.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "risk management" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ich-q9r1", "quote_allowed": true, "snapshot_available": true, "rights_of": "ich-q9r1" }, { "id": "iec-62304", "title": "IEC 62304 — Medical device software life cycle processes", "short_title": "IEC 62304", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/38421.html", "secondary_urls": [], "topics": [ "software" ], "summary": "Standard defining life cycle requirements for medical device software, including software safety classification.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "software" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iec-62304", "quote_allowed": false, "snapshot_available": true, "rights_of": "iec-62304" }, { "id": "iec-62443", "title": "IEC 62443 series — Security for industrial automation and control systems", "short_title": "IEC 62443", "authority": "IEC / ISA", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.isa.org/standards-and-publications/isa-standards/isa-iec-62443-series-of-standards", "secondary_urls": [], "topics": [ "security" ], "summary": "Standard family addressing security for industrial automation and control systems, including secure development lifecycle requirements and component security requirements.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows GPTBot", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iec-62443", "quote_allowed": false, "snapshot_available": true, "rights_of": "iec-62443" }, { "id": "iec-81001-5-1", "title": "IEC 81001-5-1 — Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle", "short_title": "IEC 81001-5-1", "authority": "IEC", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://webstore.iec.ch/en/publication/63293", "secondary_urls": [], "topics": [ "security" ], "summary": "IEC catalogue entry for a standard on security activities in the product life cycle of health software and health IT systems. The text is sold rather than published.", "watch_cadence": "monthly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iec-81001-5-1", "quote_allowed": false, "snapshot_available": true, "rights_of": "iec-81001-5-1" }, { "id": "ieee-7000", "title": "IEEE 7000 series — Ethical and systems standards for AI", "short_title": "IEEE 7000", "authority": "Institute of Electrical and Electronics Engineers", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://standards.ieee.org/ieee/7000/6781/", "secondary_urls": [], "topics": [], "summary": "Series of IEEE standards addressing ethical and systems considerations in the design of autonomous and intelligent systems.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "disallows GPTBot", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/ieee-7000", "quote_allowed": false, "snapshot_available": true, "rights_of": "ieee-7000" }, { "id": "imdrf-aiml-wg", "title": "IMDRF artificial intelligence working group outputs", "short_title": "IMDRF AI/ML WG", "authority": "International Medical Device Regulators Forum", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.imdrf.org/working-groups", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "Outputs of the IMDRF working group addressing artificial intelligence and machine learning in medical devices.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": false, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/imdrf-aiml-wg", "quote_allowed": true, "snapshot_available": false, "rights_of": "imdrf-aiml-wg" }, { "id": "imdrf-samd", "title": "IMDRF Software as a Medical Device documents", "short_title": "IMDRF SaMD", "authority": "International Medical Device Regulators Forum", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.imdrf.org/documents", "secondary_urls": [], "topics": [ "software" ], "summary": "Documents published by IMDRF addressing software as a medical device and machine learning.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": false, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/imdrf-samd", "quote_allowed": true, "snapshot_available": false, "rights_of": "imdrf-samd" }, { "id": "iso-13485", "title": "ISO 13485 — Medical devices, quality management systems", "short_title": "ISO 13485", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/59752.html", "secondary_urls": [], "topics": [ "quality management", "medical devices" ], "summary": "Standard specifying quality management system requirements for organisations involved in the medical device life cycle.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "medical devices", "quality management", "medical device" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-13485", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-13485" }, { "id": "iso-14971", "title": "ISO 14971 — Application of risk management to medical devices", "short_title": "ISO 14971", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/72704.html", "secondary_urls": [], "topics": [ "risk management", "medical devices" ], "summary": "Standard specifying a process for managing risks associated with medical devices, including software.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "medical devices", "medical device", "risk management" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-14971", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-14971" }, { "id": "iso-81001-1", "title": "ISO 81001-1 — Health software and health IT systems safety, effectiveness and security — Part 1: Principles and concepts", "short_title": "ISO 81001-1", "authority": "ISO", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/obp/ui/#iso:std:iso:81001:-1:ed-1:v1:en", "secondary_urls": [], "topics": [ "health software" ], "summary": "ISO Online Browsing Platform entry for the foundational part of the 81001 series on health software and health IT systems safety, effectiveness and security. The full text is not public by licence.", "watch_cadence": "monthly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": false, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "software", "health software" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-81001-1", "quote_allowed": false, "snapshot_available": false, "rights_of": "iso-81001-1" }, { "id": "iso-iec-22989", "title": "ISO/IEC 22989 — Artificial intelligence concepts and terminology", "short_title": "ISO/IEC 22989", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/74296.html", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "Standard establishing terminology and concepts for artificial intelligence.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-22989", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-22989" }, { "id": "iso-iec-23894", "title": "ISO/IEC 23894 — AI guidance on risk management", "short_title": "ISO/IEC 23894", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/77304.html", "secondary_urls": [], "topics": [ "risk management" ], "summary": "International standard providing guidance on risk management for artificial intelligence.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "risk management" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-23894", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-23894" }, { "id": "iso-iec-24028", "title": "ISO/IEC 24028 — Overview of trustworthiness in artificial intelligence", "short_title": "ISO/IEC 24028", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "artificial intelligence", "trustworthiness" ], "summary": "Technical report giving an overview of trustworthiness in artificial intelligence systems.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence", "trustworthiness" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-24028", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-24028" }, { "id": "iso-iec-27001", "title": "ISO/IEC 27001:2022 — Information security management systems", "short_title": "ISO/IEC 27001", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/27001", "secondary_urls": [], "topics": [ "security", "information security" ], "summary": "Standard specifying requirements for an information security management system. Named in the draft revision of EU GMP Annex 11 as an aligned framework.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "security", "information security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27001", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27001" }, { "id": "iso-iec-27002", "title": "ISO/IEC 27002:2022 — Information security controls", "short_title": "ISO/IEC 27002", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/75652.html", "secondary_urls": [], "topics": [ "security", "information security" ], "summary": "Companion standard to ISO/IEC 27001 setting out information security controls and implementation guidance.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "security", "information security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27002", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27002" }, { "id": "iso-iec-27017", "title": "ISO/IEC 27017 — Information security controls for cloud services", "short_title": "ISO/IEC 27017", "authority": "ISO/IEC", "jurisdiction": "International", "status": "withdrawn", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/43757.html", "secondary_urls": [], "topics": [ "security", "information security" ], "summary": "A consensus standard published as \"Information security controls for cloud services\". The text is not public by licence; this row tracks the catalogue entry.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "withdrawn" ], "jurisdiction": [ "International" ], "subject": [ "security", "information security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27017", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27017" }, { "id": "iso-iec-27017-2026", "title": "ISO/IEC 27017:2026 — Information security controls based on ISO/IEC 27002 for cloud services", "short_title": "ISO/IEC 27017:2026", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/82878.html", "secondary_urls": [], "topics": [ "information security" ], "summary": "Second edition of the ISO/IEC standard setting out information security controls for cloud services, based on ISO/IEC 27002. Recorded from the publisher's catalogue entry; the text is not public by licence.", "watch_cadence": "weekly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "security", "information security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27017-2026", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27017-2026" }, { "id": "iso-iec-27018", "title": "ISO/IEC 27018 — Protection of personally identifiable information in public clouds", "short_title": "ISO/IEC 27018", "authority": "ISO/IEC", "jurisdiction": "International", "status": "withdrawn", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/76559.html", "secondary_urls": [], "topics": [], "summary": "Standard giving a code of practice for protection of personally identifiable information processed in public cloud computing services.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "withdrawn" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27018", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27018" }, { "id": "iso-iec-27018-2025", "title": "ISO/IEC 27018:2025 — Protection of personally identifiable information in public clouds acting as PII processors", "short_title": "ISO/IEC 27018:2025", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-08", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/88150.html", "secondary_urls": [], "topics": [ "information security" ], "summary": "Third edition of the ISO/IEC standard on protection of personally identifiable information in public clouds acting as PII processors. Recorded from the publisher's catalogue entry; the text is not public by licence.", "watch_cadence": "weekly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-08", "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "security", "information security" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-27018-2025", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-27018-2025" }, { "id": "iso-iec-38507", "title": "ISO/IEC 38507 — Governance implications of the use of AI", "short_title": "ISO/IEC 38507", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "governance" ], "summary": "Standard addressing the governance implications of organisational use of artificial intelligence.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "governance" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-38507", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-38507" }, { "id": "iso-iec-42001", "title": "ISO/IEC 42001 — Artificial intelligence management system", "short_title": "ISO/IEC 42001", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/standard/81230.html", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "International standard specifying requirements for establishing and maintaining an artificial intelligence management system.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-42001", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-42001" }, { "id": "iso-iec-42005", "title": "ISO/IEC 42005 — AI system impact assessment", "short_title": "ISO/IEC 42005", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [], "summary": "Standard addressing impact assessment for artificial intelligence systems.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-42005", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-42005" }, { "id": "iso-iec-5259", "title": "ISO/IEC 5259 series — Data quality for analytics and machine learning", "short_title": "ISO/IEC 5259", "authority": "ISO/IEC", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-29", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475/x/catalogue/", "secondary_urls": [], "topics": [ "machine learning", "data quality" ], "summary": "Multi-part standard series addressing data quality for analytics and machine learning.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-07-29", "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "machine learning", "data quality" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-5259", "quote_allowed": false, "snapshot_available": true, "rights_of": "iso-iec-5259" }, { "id": "iso-iec-sc42-programme", "title": "ISO/IEC JTC 1/SC 42 work programme", "short_title": "ISO/IEC SC 42", "authority": "ISO/IEC", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": "2023-09-11", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.iso.org/committee/6794475.html", "secondary_urls": [], "topics": [], "summary": "Published work programme of the ISO/IEC subcommittee responsible for artificial intelligence standards, listing projects and their stage codes.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/iso-iec-sc42-programme", "quote_allowed": true, "snapshot_available": true, "rights_of": "iso-iec-sc42-programme" }, { "id": "ispe-gamp-ai", "title": "ISPE GAMP Guide: Artificial Intelligence", "short_title": "GAMP AI Guide", "authority": "ISPE", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://ispe.org/publications/guidance-documents", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "Industry guide published by ISPE addressing artificial intelligence within the GAMP framework.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows GPTBot", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/ispe-gamp-ai", "quote_allowed": false, "snapshot_available": true, "rights_of": "ispe-gamp-ai" }, { "id": "ispe-gamp-rdi", "title": "ISPE GAMP Guide — Records and Data Integrity", "short_title": "ISPE GAMP RDI", "authority": "International Society for Pharmaceutical Engineering", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://ispe.org/publications/guidance-documents", "secondary_urls": [], "topics": [], "summary": "ISPE guidance in the GAMP family addressing records and data integrity, sold through the society's publications catalogue.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ispe-gamp-rdi", "quote_allowed": false, "snapshot_available": true, "rights_of": "ispe-gamp-rdi" }, { "id": "ispe-gamp5-2e", "title": "ISPE GAMP 5: A Risk-Based Approach to Compliant GxP Computerized Systems (Second Edition)", "short_title": "GAMP 5 2nd Ed", "authority": "ISPE", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://ispe.org/publications/guidance-documents/gamp-5-guide-2nd-edition", "secondary_urls": [], "topics": [], "summary": "Industry guide published by ISPE addressing computerised systems in regulated environments.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows GPTBot", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ispe-gamp5-2e", "quote_allowed": false, "snapshot_available": true, "rights_of": "ispe-gamp5-2e" }, { "id": "ispe-pharma-4-0", "title": "ISPE Pharma 4.0 programme outputs", "short_title": "ISPE Pharma 4.0", "authority": "International Society for Pharmaceutical Engineering", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://ispe.org/initiatives/pharma-4.0", "secondary_urls": [], "topics": [], "summary": "ISPE programme publishing guidance and outputs on digitalisation in regulated manufacturing.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows GPTBot", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/ispe-pharma-4-0", "quote_allowed": false, "snapshot_available": true, "rights_of": "ispe-pharma-4-0" }, { "id": "mhra-ai", "title": "MHRA publications on AI and software as a medical device", "short_title": "MHRA AI", "authority": "Medicines and Healthcare products Regulatory Agency", "jurisdiction": "UK", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-30", "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/publications/software-and-artificial-intelligence-ai-as-a-medical-device", "secondary_urls": [], "topics": [ "software" ], "summary": "MHRA publications addressing software and artificial intelligence as a medical device.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 58, "band": "30-90", "first_observed": "2026-07-30" }, "corroboration_count": 0, "checked_by": "human", "check_date": "2026-07-30", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "UK" ], "subject": [ "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/mhra-ai", "quote_allowed": true, "snapshot_available": true, "rights_of": "mhra-ai" }, { "id": "mhra-ai-airlock", "title": "MHRA AI Airlock regulatory sandbox", "short_title": "MHRA AI Airlock", "authority": "Medicines and Healthcare products Regulatory Agency", "jurisdiction": "UK", "status": "unknown", "status_qualifier": null, "status_as_of": "2024-05-09", "last_verified": "2026-07-31", "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/collections/ai-airlock-the-regulatory-sandbox-for-aiamd", "secondary_urls": [], "topics": [], "summary": "MHRA regulatory sandbox for artificial-intelligence-enabled medical devices.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "UK" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/mhra-ai-airlock", "quote_allowed": true, "snapshot_available": true, "rights_of": "mhra-ai-airlock" }, { "id": "mhra-data-integrity", "title": "MHRA GxP Data Integrity Guidance and Definitions", "short_title": "MHRA data integrity", "authority": "Medicines and Healthcare products Regulatory Agency", "jurisdiction": "UK", "status": "unknown", "status_qualifier": null, "status_as_of": "2018-03-09", "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.gov.uk/government/publications/guidance-on-gxp-data-integrity", "secondary_urls": [], "topics": [ "data integrity" ], "summary": "MHRA guidance on data integrity expectations across GxP, with definitions used by inspectors.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "UK" ], "subject": [ "data integrity" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/mhra-data-integrity", "quote_allowed": true, "snapshot_available": true, "rights_of": "mhra-data-integrity" }, { "id": "nist-agent-standards", "title": "NIST standards initiative on autonomous AI agents", "short_title": "NIST agent standards", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.nist.gov/artificial-intelligence", "secondary_urls": [], "topics": [], "summary": "NIST programme of work addressing standards for autonomous artificial-intelligence agents.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nist-agent-standards", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-agent-standards" }, { "id": "nist-ai-600-1", "title": "NIST AI 600-1 — Generative AI Profile", "short_title": "NIST AI 600-1", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://nvlpubs.nist.gov/nistpubs/ai/NIST.AI.600-1.pdf", "secondary_urls": [], "topics": [], "summary": "NIST technical series publication issued as a companion profile to the AI Risk Management Framework, which is tracked separately as nist-ai-rmf.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nist-ai-600-1", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-ai-600-1" }, { "id": "nist-ai-rmf", "title": "NIST AI Risk Management Framework 1.0", "short_title": "NIST AI RMF", "authority": "US National Institute of Standards and Technology", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": "2023-01-01", "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.nist.gov/itl/ai-risk-management-framework", "secondary_urls": [], "topics": [ "risk management" ], "summary": "Voluntary framework describing functions for managing risks associated with artificial intelligence systems.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 19, "band": "1-30", "first_observed": "2026-09-07" }, "corroboration_count": null, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "absence" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "risk management" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nist-ai-rmf", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-ai-rmf" }, { "id": "nist-ai-rmf-playbook", "title": "NIST AI RMF Playbook and crosswalks", "short_title": "NIST AI RMF Playbook", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://airc.nist.gov/AI_RMF_Knowledge_Base/Playbook", "secondary_urls": [], "topics": [], "summary": "Companion resources to the NIST AI Risk Management Framework, including the playbook and crosswalks to other frameworks.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nist-ai-rmf-playbook", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-ai-rmf-playbook" }, { "id": "nist-csf", "title": "NIST Cybersecurity Framework 2.0", "short_title": "NIST CSF 2.0", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": "2024-02-26", "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://csrc.nist.gov/pubs/cswp/29/the-nist-cybersecurity-framework-csf-20/final", "secondary_urls": [ "https://nvlpubs.nist.gov/nistpubs/CSWP/NIST.CSWP.29.pdf" ], "topics": [ "cybersecurity" ], "summary": "NIST framework organising cybersecurity outcomes into functions, categories and subcategories. Referenced alongside NIST SP 800-82 in operational technology security work.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "cybersecurity", "security" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nist-csf", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-csf" }, { "id": "nist-sp-800-82", "title": "NIST SP 800-82 — Guide to Operational Technology Security", "short_title": "NIST SP 800-82", "authority": "US National Institute of Standards and Technology", "jurisdiction": "US", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://csrc.nist.gov/pubs/sp/800/82/r3/final", "secondary_urls": [], "topics": [ "security" ], "summary": "NIST guidance on securing operational technology, including industrial control systems, referenced in work harmonising OT security practice.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "US" ], "subject": [ "security" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/nist-sp-800-82", "quote_allowed": true, "snapshot_available": true, "rights_of": "nist-sp-800-82" }, { "id": "nistir-8183", "title": "NISTIR 8183 — Cybersecurity Framework Manufacturing Profile", "short_title": "NISTIR 8183", "authority": "National Institute of Standards and Technology", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://csrc.nist.gov/files/pubs/ir/8183/final/docs/nist.ir.8183.pdf", "secondary_urls": [], "topics": [], "summary": "Document published by National Institute of Standards and Technology, sourced by the publisher's own page as read on 2026-08-12.", "watch_cadence": "monthly", "first_observed": "2026-08-12", "observation_maturity": { "days": 45, "band": "30-90", "first_observed": "2026-08-12" }, "corroboration_count": null, "checked_by": "machine", "check_date": null, "record_tier": "register", "robots_policy": "absent-by-confirmation (csrc.nist.gov/robots.txt redirects to root; receipt state/ot-bodies/csrc-robots.txt)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "register" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nistir-8183", "quote_allowed": true, "snapshot_available": true, "rights_of": "nistir-8183" }, { "id": "nmpa-ai", "title": "NMPA English portal — front page", "short_title": "NMPA portal", "authority": "National Medical Products Administration", "jurisdiction": "China", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-07-28", "last_changed": null, "effective_date": null, "source_url": "https://english.nmpa.gov.cn/", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "The English-language front page of China's National Medical Products Administration portal. A navigation page; no document is tracked here.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": "human", "check_date": "2026-07-28", "record_tier": "core", "robots_policy": "absent-by-confirmation (english.nmpa.gov.cn/robots.txt returns 404; no meta-robots on the page; receipt state/referent-bodies/nmpa-english.html)", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "China" ], "subject": [ "artificial intelligence" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/nmpa-ai", "quote_allowed": true, "snapshot_available": true, "rights_of": "nmpa-ai" }, { "id": "pda-tr-80", "title": "PDA Technical Report No. 80 — Data Integrity Management System for Pharmaceutical Laboratories", "short_title": "PDA TR 80", "authority": "Parenteral Drug Association", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.pda.org/bookstore/product-detail/4542-tr-80-data-integrity-management", "secondary_urls": [], "topics": [ "data integrity" ], "summary": "Technical report published by the Parenteral Drug Association and listed in the publisher's own catalogue of current publications. The text is sold through the PDA bookstore.", "watch_cadence": "quarterly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "data integrity" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/pda-tr-80", "quote_allowed": false, "snapshot_available": true, "rights_of": "pda-tr-80" }, { "id": "pic-s", "title": "PIC/S Guide to Good Manufacturing Practice", "short_title": "PIC/S GMP Guide", "authority": "Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://picscheme.org/en/publications", "secondary_urls": [], "topics": [ "good manufacturing practice", "manufacturing" ], "summary": "GMP guide maintained by PIC/S and applied by participating inspectorates, including annexes on computerised systems and data integrity.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "manufacturing", "good manufacturing practice" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/pic-s", "quote_allowed": false, "snapshot_available": true, "rights_of": "pic-s" }, { "id": "pics-annex-11", "title": "PIC/S GMP Guide, Annex 11 — Computerised Systems", "short_title": "PIC/S Annex 11", "authority": "Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://picscheme.org/en/publications?tri=gmp", "secondary_urls": [], "topics": [ "computerised systems" ], "summary": "The PIC/S GMP guide annex on computerised systems, published and revised separately from the EU instrument of the same number.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "computerised systems" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/pics-annex-11", "quote_allowed": true, "snapshot_available": true, "rights_of": "pics-annex-11" }, { "id": "pics-pi-011", "title": "PIC/S PI 011 — Good practices for computerised systems in regulated GxP environments", "short_title": "PIC/S PI 011", "authority": "Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://picscheme.org/en/publications", "secondary_urls": [], "topics": [], "summary": "PIC/S guidance document on good practices for computerised systems in regulated GxP environments, distributed from the scheme's publications index.", "watch_cadence": "quarterly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/pics-pi-011", "quote_allowed": true, "snapshot_available": true, "rights_of": "pics-pi-011" }, { "id": "pics-pi041", "title": "PIC/S PI 041 — Good Practices for Data Management and Integrity", "short_title": "PIC/S PI 041", "authority": "Pharmaceutical Inspection Co-operation Scheme", "jurisdiction": "International", "status": "final", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://picscheme.org/en/publications", "secondary_urls": [], "topics": [], "summary": "PIC/S document addressing good practices for data management and integrity in regulated environments.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "final" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/pics-pi041", "quote_allowed": true, "snapshot_available": true, "rights_of": "pics-pi041" }, { "id": "pmda-ai", "title": "PMDA publications on AI in medical products", "short_title": "PMDA AI", "authority": "Pharmaceuticals and Medical Devices Agency", "jurisdiction": "Japan", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.pmda.go.jp/english/", "secondary_urls": [], "topics": [], "summary": "PMDA publications addressing artificial intelligence in medical products.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "Japan" ], "subject": [ "unstated" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/pmda-ai", "quote_allowed": true, "snapshot_available": true, "rights_of": "pmda-ai" }, { "id": "pren-18229-1", "title": "prEN 18229-1 — Trustworthiness framework for AI (Part 1)", "short_title": "prEN 18229-1", "authority": "CEN/CENELEC JTC 21", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/", "secondary_urls": [], "topics": [ "trustworthiness" ], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "trustworthiness" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/pren-18229-1", "quote_allowed": false, "snapshot_available": true, "rights_of": "pren-18229-1" }, { "id": "pren-18229-2", "title": "prEN 18229-2 — Trustworthiness framework for AI (Part 2)", "short_title": "prEN 18229-2", "authority": "CEN/CENELEC JTC 21", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/", "secondary_urls": [], "topics": [ "trustworthiness" ], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "trustworthiness" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/pren-18229-2", "quote_allowed": false, "snapshot_available": true, "rights_of": "pren-18229-2" }, { "id": "pren-18281", "title": "prEN 18281 — AI quality management", "short_title": "prEN 18281", "authority": "CEN/CENELEC JTC 21", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/", "secondary_urls": [], "topics": [ "quality management" ], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "quality management" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/pren-18281", "quote_allowed": false, "snapshot_available": true, "rights_of": "pren-18281" }, { "id": "pren-18282", "title": "prEN 18282 — AI conformity assessment", "short_title": "prEN 18282", "authority": "CEN/CENELEC JTC 21", "jurisdiction": "EU", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.cencenelec.eu/areas-of-work/cen-cenelec-topics/artificial-intelligence/", "secondary_urls": [], "topics": [], "summary": "Draft European standard developed under CEN/CENELEC JTC 21 in support of the EU AI Act.", "watch_cadence": "monthly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no robots.txt published", "licence_class": "restricted", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "EU" ], "subject": [ "unstated" ], "class": [ "consensus standard" ] }, "url": "https://gxplex.com/r/pren-18282", "quote_allowed": false, "snapshot_available": true, "rights_of": "pren-18282" }, { "id": "swissmedic-ai", "title": "Swissmedic publications on medical device software", "short_title": "Swissmedic", "authority": "Swissmedic", "jurisdiction": "Switzerland", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.swissmedic.ch/swissmedic/en/home/medical-devices.html", "secondary_urls": [], "topics": [ "software" ], "summary": "Swissmedic publications addressing medical device software.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "Switzerland" ], "subject": [ "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/swissmedic-ai", "quote_allowed": true, "snapshot_available": true, "rights_of": "swissmedic-ai" }, { "id": "tga-samd", "title": "TGA regulation of software as a medical device", "short_title": "TGA SaMD", "authority": "Therapeutic Goods Administration", "jurisdiction": "Australia", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.tga.gov.au/products/medical-devices/software-based-medical-devices", "secondary_urls": [], "topics": [ "software" ], "summary": "TGA material addressing the regulation of software-based medical devices.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "robots.txt unreachable", "licence_class": "open", "text_retained": false, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "Australia" ], "subject": [ "software" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/tga-samd", "quote_allowed": true, "snapshot_available": false, "rights_of": "tga-samd" }, { "id": "us-21-cfr-part-11", "title": "21 CFR Part 11 — Electronic Records; Electronic Signatures", "short_title": "21 CFR Part 11", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "in-force", "status_qualifier": null, "status_as_of": "1997-08-20", "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-A/part-11", "secondary_urls": [], "topics": [ "electronic records", "electronic signatures" ], "summary": "US regulation setting criteria under which electronic records and electronic signatures are considered trustworthy and reliable.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": 1, "checked_by": "human", "check_date": "2026-08-01", "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "US" ], "subject": [ "electronic records", "electronic signatures" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/us-21-cfr-part-11", "quote_allowed": true, "snapshot_available": true, "rights_of": "us-21-cfr-part-11" }, { "id": "us-21-cfr-part-211", "title": "21 CFR Part 211 — Current Good Manufacturing Practice for Finished Pharmaceuticals", "short_title": "21 CFR Part 211", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "in-force", "status_qualifier": null, "status_as_of": null, "last_verified": "2026-08-01", "last_changed": null, "effective_date": null, "source_url": "https://www.ecfr.gov/current/title-21/chapter-I/subchapter-C/part-211", "secondary_urls": [], "topics": [ "good manufacturing practice", "manufacturing" ], "summary": "The US current good manufacturing practice regulations for finished pharmaceuticals, including provisions on automatic and electronic equipment, record retention and laboratory records.", "watch_cadence": "weekly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": 0, "checked_by": "human", "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "verified" ], "status": [ "in-force" ], "jurisdiction": [ "US" ], "subject": [ "manufacturing", "good manufacturing practice" ], "class": [ "legal act" ] }, "url": "https://gxplex.com/r/us-21-cfr-part-211", "quote_allowed": true, "snapshot_available": true, "rights_of": "us-21-cfr-part-211" }, { "id": "us-21-cfr-part-820", "title": "21 CFR Part 820 — Quality Management System Regulation", "short_title": "21 CFR Part 820 (QMSR)", "authority": "US Food and Drug Administration", "jurisdiction": "US", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.ecfr.gov/current/title-21/part-820", "secondary_urls": [], "topics": [], "summary": "US regulation setting out quality management system requirements for medical devices, codified in title 21 of the Code of Federal Regulations.", "watch_cadence": "monthly", "first_observed": "2026-08-04", "observation_maturity": { "days": 53, "band": "30-90", "first_observed": "2026-08-04" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "US" ], "subject": [ "unstated" ], "class": [ "Code of Federal Regulations" ] }, "url": "https://gxplex.com/r/us-21-cfr-part-820", "quote_allowed": true, "snapshot_available": true, "rights_of": "us-21-cfr-part-820" }, { "id": "who-ai-health", "title": "WHO guidance on artificial intelligence for health", "short_title": "WHO AI health", "authority": "World Health Organization", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": "2021-06-28", "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.who.int/publications/i/item/9789240029200", "secondary_urls": [], "topics": [ "artificial intelligence" ], "summary": "WHO guidance addressing the ethics and governance of artificial intelligence for health.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows CCBot", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "artificial intelligence" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/who-ai-health", "quote_allowed": true, "snapshot_available": true, "rights_of": "who-ai-health" }, { "id": "who-annex5-data-management", "title": "WHO Annex 5 — Guidance on Good Data and Record Management Practices", "short_title": "WHO data management", "authority": "World Health Organization", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://iris.who.int/", "secondary_urls": [], "topics": [], "summary": "WHO guidance on good data and record management practices, published as an annex to a WHO Expert Committee technical report.", "watch_cadence": "monthly", "first_observed": "2026-07-31", "observation_maturity": { "days": 57, "band": "30-90", "first_observed": "2026-07-31" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "no AI-specific disallow", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "unstated" ], "class": [ "authority guidance" ] }, "url": "https://gxplex.com/r/who-annex5-data-management", "quote_allowed": true, "snapshot_available": true, "rights_of": "who-annex5-data-management" }, { "id": "who-computerised-systems", "title": "WHO guideline on computerised systems and data integrity", "short_title": "WHO computerised systems", "authority": "World Health Organization", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://www.who.int/teams/health-product-policy-and-standards/standards-and-specifications", "secondary_urls": [], "topics": [ "data integrity", "computerised systems" ], "summary": "WHO technical guidance addressing computerised systems and data integrity in pharmaceutical manufacture.", "watch_cadence": "quarterly", "first_observed": "2026-07-28", "observation_maturity": { "days": 60, "band": "30-90", "first_observed": "2026-07-28" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "disallows CCBot", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "frozen" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "computerised systems", "data integrity" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/who-computerised-systems", "quote_allowed": true, "snapshot_available": true, "rights_of": "who-computerised-systems" }, { "id": "who-trs1033-annex4-data-integrity", "title": "WHO Annex 4 — Guideline on data integrity", "short_title": "WHO data integrity guideline", "authority": "World Health Organization", "jurisdiction": "International", "status": "unknown", "status_qualifier": null, "status_as_of": null, "last_verified": null, "last_changed": null, "effective_date": null, "source_url": "https://iris.who.int/handle/10665/340323", "secondary_urls": [ "https://www.who.int/publications/i/item/55th-report-of-the-who-expert-committee-on-specifications-for-pharmaceutical-preparations" ], "topics": [ "data integrity" ], "summary": "WHO guideline on data integrity, published as Annex 4 to WHO Technical Report Series No. 1033, the fifty-fifth report of the Expert Committee on Specifications for Pharmaceutical Preparations.", "watch_cadence": "quarterly", "first_observed": "2026-08-08", "observation_maturity": { "days": 49, "band": "30-90", "first_observed": "2026-08-08" }, "corroboration_count": null, "checked_by": null, "check_date": null, "record_tier": "core", "robots_policy": "", "licence_class": "open", "text_retained": true, "facets": { "verification": [ "awaiting" ], "status": [ "unknown" ], "jurisdiction": [ "International" ], "subject": [ "data integrity" ], "class": [ "unstated" ] }, "url": "https://gxplex.com/r/who-trs1033-annex4-data-integrity", "quote_allowed": true, "snapshot_available": true, "rights_of": "who-trs1033-annex4-data-integrity" } ] }