Annex 22: EMA Workshop on AI in GMP
The European Medicines Agency (EMA) will hold a two-day multistakeholder workshop on 30 June and 1 July 2026 to gather expert input for the development of Annex 22 of the EU GMP Guide on the use of artificial intelligence (AI) in medicines manufacturing.
The workshop follows the 2025 consultation on the draft Annex 22, during which stakeholders expressed support for potentially enabling technologies such as generative AI (GenAI) and large language models (LLMs) in pharmaceutical manufacturing.
The draft had stated that dynamic, adaptive and probabilistic AI models such as GenAI and LLMs should not be used in critical GMP applications. EMA is now reassessing this position and is seeking expert input on possible control and mitigation measures, including AI guardrails and risk-based approaches.
The agency aims to collect insights on:
- Responsible AI requirements
- Risk identification and mitigation
- Data governance
- Model evaluation and transparency
- Accountability and human oversight
- Practical GMP-related implementation challenges
Participants include AI experts nominated by industry associations, academia, the European Medicines Regulatory Network and international regulatory authorities.
The first workshop day will be publicly broadcast, while the second day will consist of closed discussions within EMA’s Annex 22 drafting group.
EMA expects the workshop to result in a report summarising expert contributions and recommendations.
Source:
EMA: Events
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