Data and AI in medicines regulation, the workplan to 2028

The joint workplan “Data and AI in medicines regulation to 2028” was published by EMA and the Heads of Medicines Agencies (HMA) at the beginning of May 2025. It sets out the general framework that the European medicines regulatory network should use to leverage large volumes of regulatory and health data. The plan also discusses new tools that may prove useful to encourage research and innovation, and support regulatory decision making.

The workplan translates the objectives of the European medicines agencies network strategy to 2028 into a concrete roadmap for managing, analysing, and sharing data across the network. It also provides a framework for coordination in response to new EU legislative initiatives, such as the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act and the AI Act.

Planned initiatives include strengthening the network’s data analytics capabilities to generate high-quality evidence and reviewing methodologies such as biostatistics, modelling and simulation, AI and pharmacoepidemiology. Genomic data, synthetic data, digital twins data and patient experience data will also be considered, as well as the master data needed to increase the interoperability of data assets and systems. The workplan will also advance and harmonise the implementation of the Product Management Service (PMS), as well as evaluating AI throughout the entire medicine lifecycle.