ICH Q10 and its 5 linked instruments

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ICH Q10ICH Q9(R1)Chapter 1 (2013)Chapter 1 revisionAnnex 15EMA AI reflection paper
AuthorityICHICHEuropean CommissionEuropean CommissionEuropean CommissionEMA
Legal weightGuidance & Q&AGuidance & Q&AGMP guide & annexesGMP guide & annexesGMP guide & annexesGuidance & Q&A
StatusFinalFinalIn forceDraftIn forceFinal
Last verifiedNot yetNot yetNot yetNot yetNot yetNot yet
Summary

ICH model for an effective quality management system for the pharmaceutical industry.

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 current EU GMP chapter on the pharmaceutical quality system.

Draft revision of the EU GMP quality system chapter, recommended jointly by the GMP/GDP Inspectors Working Group and the PIC/S Committee to reflect ICH Q9(R1). Draft only.

The EU GMP annex on qualification and validation.

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
  • 8 Apr 2009 Published by FDA as guidance
  • 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)
  • 31 Jan 2013 Came into operation
  • 3 Sep 2025 Consultation document published
  • 1 Oct 2015 Came into operation
  • 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
SourceOfficial text
Source: ICH.
Official text
Source: ICH.
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: EMA.

These facts are placed side by side from each record. This page does not say which is stricter or whether requirements differ. Read the official texts.