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 under proposed Annex 22 guidance.
- Workshop focuses on control measures, guardrails, and risk-based approaches for generative AI and large language models in critical GMP applications previously flagged as prohibited.
- EMA seeks expert consensus on validation paradigms, human oversight requirements, and safeguards against hallucinations and model drift in high-risk manufacturing workflows.
Operational Impact
CDMOs and manufacturers must prepare for evolving EMA expectations on AI governance in GMP; the workshop outcomes will inform final Annex 22 rules that may enable or constrain adoption of adaptive and generative AI in critical manufacturing processes.
Source: EMA What's New RSS