GxPlex

Status: final · Class (as stated): no self-stated class

19 of 86 tracked instruments.

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

Class (as stated) no self-stated class 19 (active — select again to clear) consensus standard 10 authority guidance 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; the other groups return when one is cleared.

Showing 19 of 86 instruments. Clear all filters

Status: final · Class (as stated): no self-stated class — 19 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
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
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 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
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
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
NMPA National Medical Products Administration China final verified 2026-07-28 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

Last updated: