HMA-EMA AI workplan and its 2 linked instruments

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First column: HMA-EMA AI workplan. The others are every document linked to it.
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	HMA-EMA AI workplan	EU AI Act	EMA AI reflection paper
Authority	EMA	European Union	EMA
Legal weight	Guidance & Q&A	Law & regulation	Guidance & Q&A
Status	Final	Effective · phased	Final
Last verified	Not yet	Not yet	Not yet
Summary	Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.	Horizontal EU law on AI systems, applying in phases. AI literacy duties already apply; transparency duties (Art. 50) apply from 2 August 2026. The 2026 digital omnibus moved high-risk obligations to December 2027 (Annex III) and August 2028 (Annex I, e.g. devices).	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	18 Dec 2023 Published	1 Aug 2024 Entered into force (obligations phased) 27 Jul 2026 Digital Omnibus on AI, Regulation (EU) 2026/1744, in force (published in the Official Journal 24 Jul 2026); defers high-risk obligations 2 Aug 2026 Article 50 transparency duties apply (Art. 50(2) marking for systems already on the market: 2 Dec 2026, per the Omnibus) Target 2 Dec 2027 Annex III high-risk obligations apply Target 2 Aug 2028 Annex I (product-embedded, e.g. devices) high-risk obligations apply	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: EMA.	Official text Source: European Union. Licensed under CC BY 4.0.	Official text Source: EMA.

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