Policy & Ethicslarge language modelsmedicinal regulationemaqualification opinion
European Regulators Publish AI Workplan And Tools
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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.


