Compare ICH Q9(R1) and EMA AI reflection paper

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ICH Q9(R1) is the risk basis for EMA AI reflection paper · Source Unverified link

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	ICH Q9(R1)	EMA AI reflection paper
Authority	ICH	EMA
Legal weight	Guidance & Q&A	Guidance & Q&A
Status	Final	Final
Last verified	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.	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)	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: 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.