EMA has published the event page and supporting documents for the HMA–EMA AI group meeting with industry stakeholders (February 2026) and subsequently posted summary notes. This is a concrete regulatory mechanism for aligning expectations on acceptable AI use, governance, and evidence—also in areas that can impact GMP/CMC and lifecycle data.
Notably, the current guidance development activities mentioned include:
- Guidance on AI in clinical development (a concept paper is expected before a full draft guideline).
- Guidance on AI in pharmacovigilance, to be developed jointly with PRAC as a Q&A-style document.
- EU GMP Annex 22 on AI in manufacturing: following public consultation (≈1,300 comments received), it is now under revision, with the final document expected by the end of the year.
- Several industry interventions were noted, including an expectation for a more flexible approach to the use of AI in GMP. This includes the potential use of generative AI and large language models (LLMs) in critical GMP applications, provided this is supported by a robust, risk-based framework.
Event page (EMA): https://www.ema.euro … olders-february-2026
Summary notes PDF (EMA): https://www.ema.euro … february-2026_en.pdf