EMA AI reflection paper and its 4 linked instruments

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First column: EMA AI reflection paper. The others are every document linked to it.
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It does not compare content. It does not say which is stricter. Read the official texts for that.

Details: Guide Definitions: every term and label explained

	EMA AI reflection paper	ICH E6(R3) GCP	ICH Q9(R1)	ICH Q10	HMA-EMA AI workplan
Authority	EMA	ICH	ICH	ICH	EMA
Legal weight	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A	Guidance & Q&A
Status	Final	Final	Final	Final	Final
Last verified	Not yet	Not yet	Not yet	Not yet	Not yet
Summary	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.	Revised ICH guideline on good clinical practice. FDA says it adds flexible, risk-based approaches and embraces innovations in trial design, conduct and technology.	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.	ICH model for an effective quality management system for the pharmaceutical industry.	Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.
Lifecycle	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	8 Sep 2025 Published by FDA as final 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)	8 Apr 2009 Published by FDA as guidance	18 Dec 2023 Published
Source	Official text Source: EMA.	Official text Source: ICH.	Official text Source: ICH.	Official text Source: ICH.	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.