GxPlex

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.

Status unknown 3 frozen 16 final 6 in-force 3

Ordered by the lifecycle the values themselves name.

Jurisdiction International 15 EU 7 US 4 UK 1 Japan 1

Ordered by count, then alphabetically.

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

Subject (as stated): no self-stated subject — 28 instrument(s) — no change has been detected yet, so rows are alphabetical; they order by change date as soon as one is
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)

Last updated: