EMA/HMA Data and AI Work Plan 2025-2028

Date

May 7, 2025

Category

EU Regulations

Description

On 7 May 2025 the EMA and the Heads of Medicines Agencies (HMA) published a joint workplan "Data and AI in medicines regulation to 2028", see Leveraging the power of data for public and animal health | European Medicines Agency (EMA). This 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.

A new strategic advisory group, combining the former Big Data Steering Group and the Network Data Board, will oversee the implementation of the workplan.