EMA and HMA publish joint workplan on data and AI in medicines regulation
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint workplan titled ‘Data and AI in medicines regulation to 2028’ outlining their strategy for optimising the use of data and artificial intelligence (AI) in medicines regulation through to 2028. The workplan details how the European medicines regulatory network will manage, analyse, and share regulatory and health data and provides a framework for addressing new EU legislative initiatives, including the European Health Data Space, Interoperable Europe Act, and EU AI Act. It also aims to streamline the discovery, access, and use of the network’s data assets by cataloguing and enhancing data quality, focusing on real-world data, adverse drug reaction data, and medicinal product master data. In addition, the workplan will advance the implementation of the Product Management Service (PMS), which serves as the network’s source of product master data for all EU medicinal products. Key initiatives also include supporting EMA’s scientific committees and the pharmaceutical industry in evaluating AI throughout the medicines lifecycle and developing guidance on the use of AI in clinical development and pharmacovigilance, among other areas. The Network Data Steering Group will oversee the implementation of the workplan.