Tuesday, May 12, 2026

EMA workshop planned for 30 June 2026 on expert contributions to the development of AI Annex 22


Introduction⇒ EMA’s Annex 22 workshop will examine risk-based controls, guardrails, validation and human oversight for GenAI and LLMs in GMP manufacturing.

Noteworthy developments are emerging in the context of the new Annex 22, particularly following the EMA workshop planned on expert contributions to AI guidance development. For more details, you can refer to the workshop information provided by the EMA. https://www.ema.euro … development-annex-22

Thursday, March 5, 2026

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


Introduction⇒ FDA deploys Elsa, an internal generative AI tool designed to accelerate scientific reviews, analyse regulatory data and support agency-wide workflows.

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

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