EMA convenes workshop on AI guidance for Annex 22

EMA's Good Manufacturing Practice (GMP) / Good Distribution Practice (GDP) Inspectors Working Group is organising a two-day online workshop on 30 June 2026 and 1 July 2026 to collect expert contributions for the draft Annex 22 guidance on the use of artificial intelligence (AI) in medicines manufacturing, according to the EMA event page. Per EMA, the first day is an open session for expert presentations and the second day is a closed drafting-group review; EMA expects the workshop to produce a report with expert input. The EMA event page also states that a 2025 stakeholder consultation suggested support for potentially enabling technologies such as GenAI and LLMs, while the draft Annex 22 previously indicated that dynamic, adaptive and probabilistic models should not be used in critical GMP applications.

The HMA/EMA 2025 multi-stakeholder workshop report documents senior regulator remarks about balancing opportunity and responsibility. Emer Cooke, Executive Director of the European Medicines Agency, is quoted summarising the collaborative aim: "we're all in this together," per the 2025 workshop report. The report frames regulatory work on AI within a broader legislative ecosystem that includes the European Health Data Space, the proposed AI Act, and clinical trial and HTA rules.

Industry observers note that guidance for regulated manufacturing typically focuses on data governance, validation, transparency, and human oversight. For regulated machine-learning or probabilistic systems, practitioners frequently emphasise reproducible training data pipelines, traceable model evaluation, and controls to limit model-driven variability. These are the types of safeguards mentioned in EMA's workshop objectives as areas for expert input.

Guidance labelled as Annex 22 affects manufacturers subject to GMP because it aims to define acceptable controls and mitigation measures for AI use in production and quality systems. The EMA event and the earlier workshop report signal regulatory attention to whether and how adaptive AI systems can be introduced in highly controlled manufacturing environments.

Observers should look for the EMA workshop report summarising expert input, any revisions to the draft Annex 22 that follow publication of that report, and whether the Annex 22 drafting group updates language on dynamic, adaptive, or probabilistic models in critical GMP applications. Tracking references to specific mitigations such as model evaluation frameworks, data lineage requirements, and human-in-the-loop controls will indicate practical implications for implementers.