EMA And FDA Align On Good AI Practice In Drug Development

On January 14, 2026, the European Medicines Agency ("EMA") and the U.S. Food and Drug Administration ("FDA") published a joint set of Guiding Principles of Good AI Practice in Drug Development (the "Principles"), setting out a shared regulatory vision for the use of artificial intelligence ("AI") across the full medicines life cycle. The collaborative EMA-FDA initiative aims to maximize AI's potential for accelerating the path from innovation to safe and effective medicines while safeguarding patients and maintaining reliable data and regulatory standards.

The Principles provide high-level guidance for drug developers, marketing authorization applicants, and holders on how AI should be used to generate and monitor evidence across all stages of the medicines life cycle, from early research and clinical development to manufacturing and post-marketing safety activities. The Principles are intended to inform future regulatory policies and guidance across jurisdictions