European Regulators Publish AI Workplan And Tools
The European medicines regulatory network issues a multi‑annual AI workplan (2025–2028) and related documents, including a September 2024 reflection paper, LLM guiding principles, and the first AI Observatory annual report covering 2024. EMA extended its Scientific Explorer knowledge‑mining tool in March 2026, and CHMP issued a March 2025 qualification opinion accepting AI‑assisted AIM‑NASH evidence; EMA and FDA published ten joint AI principles.
Key Points
- 1Publish network AI workplan 2025–2028 with guidance, tools, collaboration, and experimentation focus.
- 2Issue CHMP qualification accepting AI-assisted AIM‑NASH evidence, marking scientific validity of AI-generated clinical data.
- 3Enable regulators to search EMA precedents with Scientific Explorer extension, improving evidence retrieval and decision-making.
Scoring Rationale
Strong official EMA guidance and first AI qualification opinion; limited novelty beyond regulatory implementation scope.
Sources
Public references used for this report.
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