The European Medicines Agency (EMA) has published the outcomes of its 21st Industry Stakeholder Platform on the Operation of EU Pharmacovigilance Legislation, held on 20 October 2026. The discussions covered artificial intelligence (AI) in safety monitoring, the expansion of the DARWIN EU real-world evidence network, EudraVigilance reporting performance and upcoming revisions to Good Pharmacovigilance Practices (GVP). Several developments have direct implications for marketing authorisation holders, particularly regarding signal monitoring,...

An announcement referring to an "EMA inspection" does not necessarily mean that EMA inspectors will visit your manufacturing site. The European Medicines Agency (EMA) coordinates certain inspection activities, while national competent authorities (NCAs) carry them out. The inspectors arriving at your site will therefore normally represent a national authority. The practical questions are which authority is responsible, why an inspection is being requested, and what EMA coordinates behind the...

The UK Health Research Authority (HRA) and the Medicines and Healthcare products Regulatory Agency (MHRA) have published findings from a joint pilot evaluating Inclusion and Diversity Plans in clinical research. The regulators have also updated their guidance for sponsors and researchers, highlighting the practical benefits of early diversity planning and areas requiring further clarification. Background to the pilot The HRA and MHRA began developing joint guidance on Inclusion and Diversity Plans...

MedTech Europe’s Facts & Figures 2026 report estimates the European medical technology market at €173 billion in 2025. Although the sector continues to expand its workforce and maintain strong patent activity, market growth has slowed to 1.8%, while Europe’s share of the global market has fallen to 25.6%. The annual report, published on 6 October 2026, examines the economic footprint, employment, innovation, healthcare expenditure and international trade of the European...

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...