Class (as stated): no self-stated class
43 of 86 tracked instruments.
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Ordered by the lifecycle the values themselves name.
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+9 more
data integrity 2 quality management 1 validation 2 clinical 2 cybersecurity 2 electronic records 1 electronic signatures 1 machine learning 1 computer software 1Values match by containment: a document stating "information security" appears under "security", because one string contains the other and no mapping between words is applied.
The words a document uses about itself. One that uses none is filed under "no self-stated class" — a fact about the reading, not a kind of document.
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Showing 43 of 86 instruments. Clear all filters
| Instrument | Authority | Jurisdiction | Status | Last verified | Last changed | Source |
|---|---|---|---|---|---|---|
| ANVISA | Agência Nacional de Vigilância Sanitária | Brazil | not yet verified frozen listing only | — | — | link (opens in new tab) |
| CEN/CLC JTC 21 | CEN/CENELEC | EU | not yet verified frozen not a document | — | — | link (opens in new tab) |
| DI revision concept paper | European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
| EMA AI reflection paper | European Medicines Agency | EU | final check unrecorded | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EMA CT computerised systems | European Medicines Agency | EU | final verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| EMA work programme | European Medicines Agency | EU | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU GMP Chapter 4 | European Commission | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA AI device list | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| FDA AI guidance | US Food and Drug Administration | US | draft — recorded as draft against the primary source verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA CDRH AI/ML | US Food and Drug Administration | US | draft — recorded as draft against the primary source verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA CSA | US Food and Drug Administration | US | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| FDA data integrity | US Food and Drug Administration | US | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| FDA device cybersecurity | US Food and Drug Administration | US | not yet verified awaiting | — | — | link (opens in new tab) |
| FDA ETP | US Food and Drug Administration | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| FDA Part 11 scope | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA PCCP | US Food and Drug Administration | US | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| FDA process analytical framework | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA software validation | US Food and Drug Administration | US | final tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA/EMA AI principles | US Food and Drug Administration and European Medicines Agency | International | not yet verified awaiting | — | — | link (opens in new tab) |
| GAMP 5 2nd Ed | ISPE | International | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| Health Canada ML | Health Canada | Canada | draft — under consultation verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| ICH E6(R3) | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q12 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q13 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q14 | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ICH Q2(R2) | International Council for Harmonisation | International | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| ICH Q9(R1) | International Council for Harmonisation | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| IMDRF AI/ML WG | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| IMDRF SaMD | International Medical Device Regulators Forum | International | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| ISPE Pharma 4.0 | International Society for Pharmaceutical Engineering | International | not yet verified frozen not a document | — | — | link (opens in new tab) |
| MHRA AI | Medicines and Healthcare products Regulatory Agency | UK | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| MHRA AI Airlock | Medicines and Healthcare products Regulatory Agency | UK | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| NIST agent standards | US National Institute of Standards and Technology | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| NIST AI RMF | US National Institute of Standards and Technology | International | not yet verified checked — no status stated | 2026-08-01 | — | link (opens in new tab) · retrieved |
| NIST AI RMF Playbook | US National Institute of Standards and Technology | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| NIST CSF 2.0 | US National Institute of Standards and Technology | US | final verified | 2026-08-01 | — | link (opens in new tab) · retrieved |
| NMPA | National Medical Products Administration | China | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| PIC/S PI 041 | Pharmaceutical Inspection Co-operation Scheme | International | final verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| PMDA AI | Pharmaceuticals and Medical Devices Agency | Japan | not yet verified frozen listing only | — | — | link (opens in new tab) |
| Swissmedic | Swissmedic | Switzerland | not yet verified frozen listing only | — | — | link (opens in new tab) |
| TGA SaMD | Therapeutic Goods Administration | Australia | not yet verified frozen blocks automated requests | — | — | link (opens in new tab) |
| WHO AI health | World Health Organization | International | final tool-read | 2026-07-30 | — | link (opens in new tab) · retrieved |
| WHO computerised systems | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
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