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Sources

Every primary source used by this tracker, grouped by issuing authority. All are published documents, publicly available from the authority that issued them.

CEN/CENELEC JTC 21

European Commission

EU GMP Annex 11 — primary source
EU GMP Annex 22 — primary source

European Medicines Agency

EMA QIG — primary source

European Parliament and Council

European Union Aviation Safety Agency

EASA AI — primary source

Health Canada

Health Canada ML — primary source

ISO/IEC

ISO/IEC 23894 — primary source
ISO/IEC 42001 — primary source

ISPE

GAMP AI Guide — primary source
GAMP 5 2nd Ed — primary source

International Council for Harmonisation

International Medical Device Regulators Forum

IMDRF SaMD — primary source

Medicines and Healthcare products Regulatory Agency

MHRA AI — primary source

Pharmaceutical Inspection Co-operation Scheme

PIC/S GMP Guide — primary source

Pharmaceuticals and Medical Devices Agency

PMDA AI — primary source

Swissmedic

Swissmedic — primary source

Therapeutic Goods Administration

TGA SaMD — primary source

US Food and Drug Administration

US National Institute of Standards and Technology

NIST AI RMF — primary source

United Nations Economic Commission for Europe

UNECE WP.29 — primary source

Last updated: 28 July 2026