The European Medicines Agency (EMA), together with the Heads of Medicines Agencies (HMA), has published a joint workplan “Data and AI in medicines regulation to 2028” to harness data and tools to drive research, support regulatory decisions, and accelerate access to better medicines.
The workplan aims to improve data sharing, quality, and interoperability across the EU regulatory network, while upholding high security and ethical standards. It supports coordination on new key legislative initiatives, including the EU pharmaceutical legislation, EHDS, Interoperable Europe Act, and AI Act, and aims to improve discovery, access, and use of data assets, starting with real-world data, adverse drug reaction data, and medicinal product master data.
AI has huge potential in the lifecycle of medicines. The actions outlined in the workplan aim to facilitate the safe and responsible use of AI to benefit public and animal health.
Learn more about the workplan here.