ICH Q9(R1) and its 7 linked instruments

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First column: ICH Q9(R1). The others are every document linked to it.
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	ICH Q9(R1)	Annex 11 revision	ICH Q10	Annex 15	FDA data integrity Q&A	FDA quality systems guide	MHRA GxP data integrity	EMA AI reflection paper
Authority	ICH	European Commission	ICH	European Commission	FDA	FDA	MHRA	EMA
Legal weight	Guidance & Q&A	GMP guide & annexes	Guidance & Q&A	GMP guide & annexes	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Final	Draft	Final	In force	Final	Final	Final	Final
Last verified	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet	Not yet
Summary	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.	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.	ICH model for an effective quality management system for the pharmaceutical industry.	The EU GMP annex on qualification and validation.	FDA's question-and-answer guidance on data integrity in drug manufacturing: ALCOA, audit trail review, access controls, shared logins and when electronic data are CGMP records.	FDA guidance to help manufacturers use modern quality systems and risk management to meet the CGMP regulations in 21 CFR parts 210 and 211.	UK guidance and definitions for data integrity across GxP areas, including data governance, ALCOA+, audit trails and computerised system controls.	EMA's current thinking on AI and machine learning for human and veterinary medicines, covering principles that apply at any stage of a medicine's lifecycle, from drug discovery to after authorisation.
Lifecycle	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)	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)	8 Apr 2009 Published by FDA as guidance	1 Oct 2015 Came into operation	~1 Dec 2018 Final guidance published (Dec 2018)	2 Oct 2006 Final guidance issued	23 Jan 2015 Earlier GMP data integrity definitions and guidance first published 13 Mar 2015 Earlier GMP guidance updated with clarifications 9 Mar 2018 Published 4 Apr 2018 Earlier GMP guidance withdrawn, replaced by this GxP guidance	19 Jul 2023 Draft released for public consultation 31 Dec 2023 Public consultation closed 9 Sep 2024 Final version adopted by CHMP 30 Sep 2024 Final version published
Source	Official text Source: ICH.	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.	Official text Source: FDA. Public domain.	Official text Source: FDA. Public domain.	Official text Source: MHRA. Contains public sector information licensed under the Open Government Licence v3.0.	Official text Source: EMA.

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