Details: Change Log · Life Science & Pharma: GxP - AI
Dated changes for Life Science & Pharma: GxP - AI, newest first. Targets and routine checks are left out.
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Date
Area
Regulator
Change Type
Status
Category and Sub Category
2026 (6)
- 2 Aug 2026In forceEU AI Act: Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus)Effective · phasedAI · Regulation
- 27 Jul 2026UpdatedEU AI Act: Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligationsEffective · phasedAI · Regulation
- 30 Jun 2026WorkshopEC Annex 22 · AI: EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul)DraftAI · Annex
- 2 Apr 2026Warning letterFDA AI warning letter: Warning letter 320-26-58 issued (2 Apr 2026)Warning letterAI · Enforcement
- 2 Apr 2026PublishedNMPA AI opinions: Issued by NMPAFinalAI · Guidance
- 14 Jan 2026PublishedFDA–EMA AI principles: Published jointly by FDA and EMA (non-binding principles)FinalAI · Principles
2025 (4)
- 7 Oct 2025Consultation closedEC Annex 22 · AI: Public consultation closedDraftAI · Annex
- 7 Jul 2025Consultation openEC Annex 22 · AI: Draft published for public consultationDraftAI · Annex
- ~1 Jul 2025PublishedISPE GAMP AI guide: Published (July 2025, month only on ISPE's public page)Industry guideAI · Industry guide
- 7 Jan 2025Draft publishedFDA AI guidance (drugs): Draft guidance published (comments closed 7 Apr 2025)DraftAI · Guidance
2024 (4)
- 30 Sep 2024PublishedEMA AI reflection paper: Final version publishedFinalAI · Guideline
- 9 Sep 2024AdoptedEMA AI reflection paper: Final version adopted by CHMPFinalAI · Guideline
- 1 Aug 2024In forceEU AI Act: Entered into force (obligations phased)Effective · phasedAI · Regulation
- 30 Apr 2024PublishedMHRA AI regulation paper: PublishedFinalAI · Guidance
2023 (4)
- 31 Dec 2023Consultation closedEMA AI reflection paper: Public consultation closedDraftAI · Guideline
- 18 Dec 2023PublishedHMA-EMA AI workplan: PublishedFinalAI · Guidance
- 19 Jul 2023Consultation openEMA AI reflection paper: Draft released for public consultationDraftAI · Guideline
- 18 Jan 2023AdoptedICH Q9(R1): Reached Step 4 (final)FinalQuality foundations · Guideline
2022 (1)
- 29 Jul 2022PublishedISPE GAMP 5, 2nd ed.: Second edition published (29 Jul 2022)Industry guideCSV · Industry guide
2021 (1)
- 18 Nov 2021Draft publishedICH Q9(R1): Q9(R1) released for public consultation at Step 2DraftQuality foundations · Guideline
2005 (1)
- 9 Nov 2005PublishedICH Q9(R1): Original Q9 reached Step 4FinalQuality foundations · Guideline