The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have jointly developed Guiding principles of good AI practice in drug development (January 2026). The Document sets out ten principles for the responsible use of artificial intelligence (AI) in generating and analysing evidence throughout the medicines lifecycle. This overview examines the principles and their implications for data governance, risk-based validation, model performance assessment and lifecycle oversight. A common framework for AI across the medicines lifecycle AI technologies are increasingly being used to generate and analyse evidence throughout the...