RegDivergence-101: An LLM Benchmark for Cross-Jurisdiction Regulatory Contradiction Detection in Life Sciences
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 relationship as AGREE, DIVERGE, or SILENT. SILENT is inh...
| Authors | Chuchu Wu, Zhiyin Zhou, Jingzhuo Hu et al. |
|---|---|
| Primary category | cs.AI |
| Published | 8 July 2026 |
| Last updated at source | 8 July 2026 |
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