Subject (as stated): no self-stated subject
28 of 86 tracked instruments.
These documents state nothing about their own subject in the text this site reads. That is a fact about the reading, not a category they belong to.
This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.
Subject (as stated) no self-stated subject 28 (active — select again to clear) artificial intelligence 13 software 9 medical devices 7 security 7 computerised systems 5 manufacturing 5 risk management 4
+15 more
data integrity 3 information security 3 quality management 3 trustworthiness 3 validation 3 clinical 2 cybersecurity 2 electronic records 2 electronic signatures 2 good manufacturing practice 2 machine learning 2 computer software 1 data quality 1 governance 1 in vitro diagnostic 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.
Class (as stated) no self-stated class 15 consensus standard 7 authority guidance 4 legal act 2
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.
Two facets compose at a time.
Showing 28 of 86 instruments. Clear all filters
| Instrument | Authority | Jurisdiction | Status | Last verified | Last changed | Source |
|---|---|---|---|---|---|---|
| Annex 11 concept paper | European Medicines Agency | EU | not yet verified awaiting | — | — | link (opens in new tab) |
| Annex 15 revision concept paper | European Medicines Agency and Pharmaceutical Inspection Co-operation Scheme | International | not yet verified awaiting | — | — | link (opens in new tab) |
| ASTM E2363 | ASTM International | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ASTM E2537 | ASTM International | International | final tool-read paywalled — progression tracked | 2026-07-31 | — | link (opens in new tab) · retrieved |
| 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 work programme | European Medicines Agency | EU | final verified | 2026-07-28 | — | link (opens in new tab) · retrieved |
| EU Cyber Resilience Act | European Parliament and Council | EU | in force tool-read | 2026-07-31 | — | 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 |
| EU NIS2 Directive | European Parliament and Council | EU | in force tool-read | 2026-07-31 | — | link (opens in new tab) · retrieved |
| FDA ETP | US Food and Drug Administration | US | not yet verified frozen not a document | — | — | link (opens in new tab) |
| FDA guidance agenda | US Food and Drug Administration | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| 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) |
| ICH Q12 | 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 |
| IEEE 7000 | Institute of Electrical and Electronics Engineers | International | final verified | 2026-07-30 | — | link (opens in new tab) · retrieved |
| ISO/IEC 27018 | ISO/IEC | International | withdrawn verified paywalled — progression tracked | 2026-08-01 | — | link (opens in new tab) · retrieved |
| ISO/IEC 42005 | ISO/IEC | International | final verified | 2026-07-29 | — | link (opens in new tab) · retrieved |
| ISO/IEC SC 42 | ISO/IEC | International | not yet verified frozen not a document | 2026-07-31 | — | link (opens in new tab) · retrieved |
| ISPE Pharma 4.0 | International Society for Pharmaceutical Engineering | International | not yet verified frozen not a document | — | — | link (opens in new tab) |
| 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 Playbook | US National Institute of Standards and Technology | US | not yet verified frozen register states no status | — | — | link (opens in new tab) |
| 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) |
| prEN 18282 | CEN/CENELEC JTC 21 | EU | not yet verified frozen paywalled — progression tracked | — | — | link (opens in new tab) |
| WHO data management | World Health Organization | International | not yet verified frozen listing only | — | — | link (opens in new tab) |
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