Annex 11 revision and its 5 linked instruments

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First column: Annex 11 revision. The others are every document linked to it.
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	Annex 11 revision	Annex 11 (2011)	Annex 22 · AI	Chapter 4 revision	ICH Q9(R1)	Annex 15
Authority	European Commission	European Commission	European Commission	European Commission	ICH	European Commission
Legal weight	GMP guide & annexes	GMP guide & annexes	GMP guide & annexes	GMP guide & annexes	Guidance & Q&A	GMP guide & annexes
Status	Draft	In force	Draft	Draft	Final	In force
Last verified	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet
Summary	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.	The current EU GMP annex for computerised systems used in GMP-regulated activities. It covers risk management, validation, data, audit trails, security, electronic signatures, periodic evaluation and business continuity. It stays in force until the revised Annex 11 is published and comes into operation.	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.	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.	The international guideline on quality risk management. It is the basis for scaling validation effort to risk in Annex 11, Annex 22 and computer software assurance, and the 2023 revision addresses subjectivity, formality and risk-based decision-making.	The EU GMP annex on qualification and validation.
Lifecycle	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)	~1 Jan 2011 Revision 1 published in EudraLex Volume 4 (January 2011) 30 Jun 2011 Came into operation	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)	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)	9 Nov 2005 Original Q9 reached Step 4 18 Nov 2021 Q9(R1) released for public consultation at Step 2 18 Jan 2023 Reached Step 4 (final)	1 Oct 2015 Came into operation
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.	Official text Source: European Commission. Licensed under CC BY 4.0.	Official text Source: ICH.	Official text Source: European Commission. Licensed under CC BY 4.0.

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