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Regulators are starting to use AI to read dossiers faster. If they shared one tool, it could show where their questions overlap and where they truly disagree.
FDA deployed an internal generative AI assistant agency-wide in 2025; EMA and MHRA have pilots. Each is used in isolation. The proposal is a jointly governed assistant with an audit trail that, for a given dossier, drafts the assessment sections for each participating agency's template, flags inconsistencies between the dossier and the trial registry, and surfaces where two agencies' historical decisions on similar evidence diverged. Reviewers retain all decisions; the tool exposes divergence.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.
Shares AI that is built but not validated or deployed, Regulatory divergence between regions.