EU GMP Annex 22: Artificial Intelligence (draft)

European Commission · Draft

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Summary

The first EU GMP text written specifically for AI, drafted with PIC/S. It covers AI models used in GMP-critical applications and complements the revised Annex 11 and Chapter 4.

• Static, deterministic models may be used in critical applications, subject to validation.
• Dynamic models, generative AI and LLMs are kept out of critical uses in the current draft; non-critical use needs documented human oversight.
• Whether generative AI can be allowed with guardrails was discussed at the June 2026 workshop.

Dated events

1. Target 31 Dec 2026 Target: final text to European Commission (Q4 2026) Source for Target: final text to European Commission (Q4 2026)
2. 29 Sep 2026 Checked: not yet in EudraLex Vol 4 Source for Checked: not yet in EudraLex Vol 4
3. 30 Jun 2026 EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul) Source for EMA multistakeholder workshop on comments and generative AI (30 Jun–1 Jul)
4. 7 Oct 2025 Public consultation closed Source for Public consultation closed
5. 7 Jul 2025 Draft published for public consultation Source for Draft published for public consultation

Official source

Official text

Source: European Commission. Licensed under CC BY 4.0.