Closing AI drug-regulatory gaps through harmonized oversight.

Artificial intelligence (AI) not only accelerates drug discovery but also creates regulatory gaps-with more than 100 AI-assisted pipelines in trials. Frameworks lack enforceable standards. We propose a risk-tiered framework that distinguishes discovery AI from evidence-generating AI, mandates impact assessments and Investigational New Drug disclosure when AI influences decisions, and transforms guidelines into binding, risk-proportionate regulation.