AIforPharma.org

EMA published a short FAQ describing “Scientific Explorer,” an AI-enabled search tool used by the EU regulatory network to find regulatory precedents. The pharma-relevant part is the transparency: EMA describes it as information retrieval, not “AI generating new decisions,” and gives concrete validation metrics (F1 score range) plus hosting/governance details (secure EU cloud; no training new models on EMA data).

https://www.ema.euro … ked-questions_en.pdf

EMA and the Heads of Medicines Agencies released their annual “AI Observatory” report, which is effectively a regulatory horizon scan of where AI is already showing up in submissions, regulator operations, and EU-funded regulatory science. A key value of this report is that it doesn’t just talk about AI—it documents where regulators see real activity and where the gaps remain (notably: “regulatory-grade” model validation and auditability).

https://www.ema.euro … vatory-report_en.pdf

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