EMA Convenes AI-in-GMP Workshop to Shape Annex 22 Guidance on Adaptive Models
- EMA hosts two-day multistakeholder workshop (30 June–1 July 2026) to gather expert input on responsible AI use in medicines manufacturing, including generative AI and large language models in GMP applications.
- Workshop focuses on validation paradigms, guardrails, human oversight, and risk-mitigation strategies for adaptive and probabilistic models in high-risk GMP workflows where defect detectability is low but patient impact is high.
- EMA's 2025 stakeholder consultation showed industry support for enabling GenAI/LLMs in manufacturing, reversing the draft Annex 22 prohibition; final guidance will incorporate expert recommendations on control measures and quality risk management.
Operational Impact
CRO and CDMO manufacturers must track Annex 22 finalization to understand which AI technologies (adaptive models, GenAI, LLMs) will be permitted in GMP workflows and what validation, guardrail, and human-oversight requirements will apply to their manufacturing operations.
Source: EMA What's New RSS