On May 7, 2025, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint workplan “Data and AI in medicines regulation to 2028”.

It sets out how the European medicines regulatory network plans to leverage large volumes of regulatory and health data as well as new tools to encourage research, innovation, and to support regulatory decision making for better medicines that reach patients faster.

The workplan lays out a roadmap for managing, analysing, and sharing data across the network, while adhering to high security and ethical standards. It also provides a framework for coordination to address new legislative initiatives in the European Union (EU), notably the pharmaceutical legislation, the European Health Data Space (EHDS), the Interoperable Europe Act and the AI Act.

The workplan translates the objectives of the European medicines agencies network strategy to 2028 into concrete deliverables. These include strengthening the network’s data analytics capabilities to generate high-quality evidence using both established and novel methods. The clinical study data pilot by EMA’s human medicines committee (CHMP) will continue to clarify the benefits and practicalities of accessing individual patient data from clinical trials.

A review of methodologies, including biostatistics, modelling and simulation, AI and pharmacoepidemiology and lesser-used data types, including genomic data, synthetic data, digital twins data and patient experience data, will help the network establish shared understanding and position the future use of such methods and data types.