Compare HMA-EMA AI workplan and EMA AI reflection paper

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HMA-EMA AI workplanEMA AI reflection paper
AuthorityEMAEMA
Legal weightGuidance & Q&AGuidance & Q&A
StatusFinalFinal
Last verifiedNot yetNot yet
Summary

Joint HMA and EMA workplan for artificial intelligence in medicines regulation, 2023 to 2028. It is a plan, not a requirement.

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
  • 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: EMA.
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.