Annex 22 · AI and its 2 linked instruments

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	Annex 22 · AI	Annex 11 revision	Chapter 4 revision
Authority	European Commission	European Commission	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes	GMP guide & annexes
Status	Draft	Draft	Draft
Last verified	Not yet	Not yet	Not yet
Summary	The first EU GMP text written specifically for AI, drafted with PIC/S. It covers AI models used in GMP-critical applications and complements the revised Annex 11 and Chapter 4. Static, deterministic models may be used in critical applications, subject to validation. Dynamic models, generative AI and LLMs are kept out of critical uses in the current draft; non-critical use needs documented human oversight. Whether generative AI can be allowed with guardrails was discussed at the June 2026 workshop.	A full rewrite of Annex 11, published for consultation with the revised Chapter 4 and the new Annex 22. It expands expectations on supplier oversight, data integrity, audit trails, identity and access, cloud and outsourced services. Not yet in force: the 2011 Annex 11 still applies.	Revised GMP documentation chapter, consulted on jointly with PIC/S. It updates expectations for records in any format, data governance and the documentation lifecycle, aligning with the revised Annex 11. Draft only.
Lifecycle	7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed 30 Jun 2026 EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul) Target 31 Dec 2026 Target: final text to European Commission (Q4 2026)	16 Nov 2022 Concept paper on revising Annex 11 (EMA/INS/GMP/778340/2022) 7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed Target 31 Dec 2026 Target: final text to European Commission (Q4 2026, slipped from Q1 2026)	7 Jul 2025 Draft published for public consultation 7 Oct 2025 Public consultation closed Target 31 Dec 2026 Target: final text to European Commission (Q4 2026)
Source	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: European Commission. Licensed under CC BY 4.0.

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