Guiding Principles of Good AI Practice in Drug Development (joint FDA–EMA)

FDA, with EMA · Final

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Summary

Ten high-level, non-binding principles agreed by FDA (CDER, CBER) and EMA for using AI to generate evidence across the medicines life cycle, including manufacturing and quality. Not a regulation or formal guidance: intended to inform future guidance on both sides of the Atlantic.

Dated events

1. 14 Jan 2026 Published jointly by FDA and EMA (non-binding principles) Source for Published jointly by FDA and EMA (non-binding principles)

Official source

Official text

Source: FDA. Public domain.