GxPlex

Verification: verified

39 of 86 tracked instruments. checked against the primary source by a person

This is a projection of the tracker, not a separate dataset. Its canonical URL is the tracker.

Status frozen 5 draft 3 final 25 in-force 6

Ordered by the lifecycle the values themselves name.

Jurisdiction International 21 EU 6 US 9 UK 1 Canada 1 China 1

Ordered by count, then alphabetically.

Class (as stated) no self-stated class 18 consensus standard 14 authority guidance 2 legal act 5

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 39 of 86 instruments. Clear all filters

Verification: verified — 39 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
21 CFR Part 11 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
21 CFR Part 211 US Food and Drug Administration US in force verified 2026-08-01 link (opens in new tab) · retrieved
ASTM E2363 ASTM International International final verified 2026-07-29 link (opens in new tab) · retrieved
ASTM E2500 ASTM International International final verified 2026-07-29 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 AI Act European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU GMP Annex 11 European Commission EU in force verified 2026-07-30 link (opens in new tab) · retrieved
EU IVDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
EU MDR European Parliament and Council EU in force verified 2026-07-28 link (opens in new tab) · retrieved
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 PCCP US Food and Drug Administration US final verified 2026-07-28 link (opens in new tab) · retrieved
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
IEEE 7000 Institute of Electrical and Electronics Engineers International final verified 2026-07-30 link (opens in new tab) · retrieved
ISO/IEC 22989 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 23894 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 24028 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 27001 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27002 ISO/IEC International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
ISO/IEC 27017 ISO/IEC International withdrawn verified paywalled — progression tracked 2026-08-01 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 38507 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
ISO/IEC 42001 ISO/IEC International final verified 2026-07-29 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 5259 ISO/IEC International final verified 2026-07-29 link (opens in new tab) · retrieved
MHRA AI Medicines and Healthcare products Regulatory Agency UK final verified 2026-07-30 link (opens in new tab) · retrieved
NIST CSF 2.0 US National Institute of Standards and Technology US final verified 2026-08-01 link (opens in new tab) · retrieved
NIST SP 800-82 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

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