Sources
Every primary source used by this tracker, grouped by issuing authority. All are published documents, publicly available from the authority that issued them.
ASTM International
- ASTM E2363 — primary source (opens in new tab) astm.org · retrieved
- ASTM E2500 — primary source (opens in new tab) astm.org · retrieved
Agência Nacional de Vigilância Sanitária
- ANVISA — primary source (opens in new tab) gov.br
CEN/CENELEC
- CEN/CLC JTC 21 — primary source (opens in new tab) cencenelec.eu
CEN/CENELEC JTC 21
- prEN 18229-1 — primary source (opens in new tab) cencenelec.eu
- prEN 18229-2 — primary source (opens in new tab) cencenelec.eu
- prEN 18281 — primary source (opens in new tab) cencenelec.eu
- prEN 18282 — primary source (opens in new tab) cencenelec.eu
European Chemicals Agency
- EU REACH — primary source (opens in new tab) echa.europa.eu
European Commission
- EU GMP Annex 11 — primary source (opens in new tab) health.ec.europa.eu · retrieved
- EU GMP Annex 22 — primary source (opens in new tab) health.ec.europa.eu · retrieved
European Food Safety Authority
- EFSA — primary source (opens in new tab) efsa.europa.eu
European Medicines Agency
- EMA AI reflection paper — primary source (opens in new tab) ema.europa.eu · retrieved
- EMA QIG — primary source (opens in new tab) ema.europa.eu
- EMA work programme — primary source (opens in new tab) ema.europa.eu · retrieved
European Parliament and Council
- EU AI Act — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU IVDR — primary source (opens in new tab) eur-lex.europa.eu · retrieved
- EU MDR — primary source (opens in new tab) eur-lex.europa.eu · retrieved
European Union Aviation Safety Agency
- EASA AI — primary source (opens in new tab) easa.europa.eu
Health Canada
- Health Canada ML — primary source (opens in new tab) canada.ca · retrieved
ISO/IEC
- ISO/IEC 22989 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 23894 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 24028 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 38507 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 42001 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 42005 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC 5259 — primary source (opens in new tab) iso.org · retrieved
- ISO/IEC SC 42 — primary source (opens in new tab) iso.org
ISPE
- GAMP AI Guide — primary source (opens in new tab) ispe.org
- GAMP 5 2nd Ed — primary source (opens in new tab) ispe.org
Institute of Electrical and Electronics Engineers
- IEEE 7000 — primary source (opens in new tab) standards.ieee.org · retrieved
International Atomic Energy Agency
International Council for Harmonisation
- ICH E6(R3) — primary source (opens in new tab) ich.org · retrieved
- ICH Q10 — primary source (opens in new tab) ich.org · retrieved
- ICH Q11 — primary source (opens in new tab) ich.org · retrieved
- ICH Q12 — primary source (opens in new tab) ich.org · retrieved
- ICH Q13 — primary source (opens in new tab) ich.org · retrieved
- ICH Q14 — primary source (opens in new tab) ich.org · retrieved
- ICH Q2(R2) — primary source (opens in new tab) ich.org · retrieved
- ICH Q8 — primary source (opens in new tab) ich.org · retrieved
- ICH Q9(R1) — primary source (opens in new tab) ich.org · retrieved
International Medical Device Regulators Forum
- IMDRF AI/ML WG — primary source (opens in new tab) imdrf.org
- IMDRF SaMD — primary source (opens in new tab) imdrf.org
International Society for Pharmaceutical Engineering
- ISPE Pharma 4.0 — primary source (opens in new tab) ispe.org
Medicines and Healthcare products Regulatory Agency
National Medical Products Administration
- NMPA — primary source (opens in new tab) english.nmpa.gov.cn · retrieved
Pharmaceutical Inspection Co-operation Scheme
- PIC/S GMP Guide — primary source (opens in new tab) picscheme.org · retrieved
- PIC/S PI 041 — primary source (opens in new tab) picscheme.org · retrieved
Pharmaceuticals and Medical Devices Agency
- PMDA AI — primary source (opens in new tab) pmda.go.jp
Swissmedic
- Swissmedic — primary source (opens in new tab) swissmedic.ch
Therapeutic Goods Administration
- TGA SaMD — primary source (opens in new tab) tga.gov.au
US Food and Drug Administration
- FDA AI guidance — primary source (opens in new tab) fda.gov · retrieved
- FDA AI device list — primary source (opens in new tab) fda.gov
- FDA CDRH AI/ML — primary source (opens in new tab) fda.gov
- FDA CSA — primary source (opens in new tab) fda.gov
- FDA data integrity — primary source (opens in new tab) fda.gov · retrieved
- FDA DHCoE — primary source (opens in new tab) fda.gov · retrieved
- FDA ETP — primary source (opens in new tab) fda.gov
- FDA guidance agenda — primary source (opens in new tab) fda.gov
- FDA PCCP — primary source (opens in new tab) fda.gov · retrieved
- 21 CFR Part 11 — primary source (opens in new tab) ecfr.gov · retrieved
- FSMA — primary source (opens in new tab) fda.gov · retrieved
US National Institute of Standards and Technology
- NIST agent standards — primary source (opens in new tab) nist.gov
- NIST AI RMF Playbook — primary source (opens in new tab) airc.nist.gov
- NIST AI RMF — primary source (opens in new tab) nist.gov · retrieved
United Nations Economic Commission for Europe
- UNECE WP.29 — primary source (opens in new tab) unece.org
World Health Organization
Last updated: