What regulators ask when AI touches a drug application

Three documents now define how the two largest medicines regulators think about artificial intelligence in drug development. The European Medicines Agency published a reflection paper in September 2024. The US Food and Drug Administration issued draft guidance in January 2025. In January 2026 the two agencies published a joint set of principles.

None of the three is binding. The FDA document is still a draft more than a year after its comment period closed in April 2025. The EMA paper sets out thinking rather than rules. The joint principles are deliberately high level. Together, though, they show what a company should expect to be asked when AI output reaches a regulatory file.