Good Manufacturing Practice: Multistakeholder Workshop on Expert Contributions to Artificial Intelligence Guidance Development (Annex 22)
EMA AI in GMP Workshop (Annex 22) – Overview
EMA will host a two-day workshop to gather expert input and evidence to inform forthcoming EU guidance on the use of artificial intelligence (AI) in medicines manufacturing (Annex 22).
- 30 June 2026 (Day 1 – Open Session): Experts will present perspectives and evidence on AI use in GMP contexts.
- 1 July 2026 (Day 2 – Closed Session): EMA’s Annex 22 drafting group will review expert contributions.
The workshop is expected to result in a report summarizing expert input.
A 2025 stakeholder consultation on the draft Annex 22 indicated support for enabling technologies such as generative AI (GenAI) and large language models (LLMs) in medicines manufacturing. However, the draft guidance previously stated that dynamic, adaptive, and probabilistic models (e.g., GenAI, LLMs) should not be used in critical GMP applications.
EMA is continuing to assess the implications of the consultation findings. As part of this process, the Annex 22 drafting group, in collaboration with the Quality Innovation Group, is seeking expert input on potential control and mitigation measures (e.g., guardrails) as part of a risk-based approach for AI use in GMP applications.
Workshop Objectives
- Gather expert insights on responsible AI requirements, including risk identification, mitigation strategies, and practical safeguards
- Identify key principles (e.g., data governance, model evaluation, transparency, accountability, human oversight)
- Assess industry-specific considerations, challenges, and operational constraints
- Explore approaches to the responsible use of AI in GMP applications
Invited Stakeholders
- AI experts nominated by industry associations
- Academia
- European Medicines Regulatory Network experts
- International regulatory authorities
Registration
Participation to this workshop is by invitation only.
Live broadcast
EMA plans to broadcast this workshop live. Details will follow in due course.