GxPlex

Jurisdiction: International · Class (as stated): no self-stated class

16 of 86 tracked instruments.

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Class (as stated) no self-stated class 16 (active — select again to clear) consensus standard 20 authority guidance 5

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Showing 16 of 86 instruments. Clear all filters

Jurisdiction: International · Class (as stated): no self-stated class — 16 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
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)
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 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)
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
PIC/S PI 041 Pharmaceutical Inspection Co-operation Scheme International final verified paywalled — progression tracked 2026-08-01 link (opens in new tab) · retrieved
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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