RegDivergence-101: An LLM Benchmark for Cross-Jurisdiction Regulatory Contradiction Detection in Life Sciences

arXiv cs.AISeptember 1, 2026en

arXiv cs.AI

AI Global Wire

arXiv:2608.28607v1 Announce Type: new Abstract: Pharmaceutical sponsors developing a drug for both the United States and the European Union must reconcile guidance issued independently by the FDA and the EMA. Where the two agencies require substantively the same thing, a sponsor can file once; where they diverge, a single trial design risks rejection in one region; where one agency is silent on a point the other regulates, the sponsor must infer obligations. Today this reconciliation is performed manually by regulatory-affairs experts. We introduce cross-jurisdiction regulatory divergence detection: given an FDA requirement and an EMA requirement on the same topic, classify their relationshi

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