Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) has published a set of principles for the responsible use of artificial intelligence in regulatory activities. The document outlines a human-centred approach, risk-based governance, data management, oversight and ongoing evaluation of AI systems used in regulatory decision-making. Scope of the principles The document, Basic Principles for the Use of AI in Regulatory Activities (Early Consideration), was issued by PMDA’s Center for Regulatory Science on 2 November 2026. It addresses activities involving regulatory judgement and decision-making across the lifecycle of pharmaceuticals, quasi-drugs, cosmetics, medical devices...