Compare ICH Q10 and EMA AI reflection paper

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ICH Q10 is related to EMA AI reflection paper · Source Unverified link

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	ICH Q10	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	ICH model for an effective quality management system for the pharmaceutical industry.	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	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.

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