AIforPharma.org

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

FDA deploys internal generative-AI tooling to speed scientific reviews (“Elsa”) + agency-wide rollout

FDA launched / expanded a generative AI tool to accelerate scientific reviews and related tasks; Reuters describes intended uses and rollout context.

FDA also issued its own announcement about completing an AI-assisted review pilot and scaling AI internally.

Why it matters for pharma: This affects how fast and how consistently regulators can process submissions, identify issues, and target inspections. Even if Elsa is “internal,” it changes the regulatory interface pharma works with.

Reuters coverage: https://www.reuters. … -reviews-2025-06-02/
FDA press announcement: https://www.fda.gov/ … ssive-agency-wide-ai