U.S. Food and Drug Administration and European Medicines Agency Publish AI Guiding Principles for Drug Development

The Center for Drug Evaluation and Research (CDER) and the Center for Biologics Evaluation and Research (CBER) of the U.S. Food and Drug Administration, together with the European Medicines Agency, have issued guiding principles to support the responsible use of artificial intelligence (AI) in drug and biological product development.

AI has the potential to reshape development and regulatory evaluation by accelerating innovation, shortening timelines, enhancing pharmacovigilance, and reducing animal testing through improved prediction of safety and efficacy. The FDA has already authorized the first AI-based tool for use in clinical trials.

To ensure reliability, patient safety, and regulatory integrity, the agencies emphasize principles including human-centric design, a risk-based approach, multidisciplinary expertise, robust data governance, sound model development practices, and lifecycle management.

The document, titled “Guiding Principles of Good AI Practice in Drug Development,” is available as a downloadable PDF.

28-02-2026