EMA’s new work plan: Leveraging data and AI to encourage innovation and research

On 7 May 2025, the European Medicines Agency (EMA) published a joint workplan with the Heads of Medicines Agencies (HMA, the national competent authorities of the EU member states) ”Data and AI in medicines regulation to 2028”, in which the Agency has underlined its ambition to better leverage large volumes of data to protect public health. The workplan also addresses recent EU legislative developments such as the EU AI Act and the European Health Data Space (EHDS).The workplan sets out a comprehensive three-year roadmap for managing, analysing and sharing data within the European medicines regulatory network. It emphasises adherence to high security and ethical standards and aims to encourage research and innovation as well as supporting regulatory decision-making, to enable better medicines to reach patients faster. A central focus of the workplan is on strengthening the capacity to generate robust, high-quality evidence by combining both traditional and innovative data sources. Ongoing pilots, such as the EMA’s Committee for Medicinal Products for Human Use (CHMP) initiative on analysis of raw data from clinical trials, are exploring ways to improve regulatory outcomes by accessing individual data. The ongoing project on access and analysis of Real-World Data (RWD) will continue in the Data Analysis and Real-World Interrogation Network (DARWIN EU®). To support these ambitions, the workplan calls for a systematic review of current methodologies across the regulatory network, including biostatistics, modelling and simulation, and the use of AI applications. This will help build a consistent approach to the use of such methods and data in future regulatory activities. In parallel, the EMA is looking to improve the organisation and accessibility of data.Key priorities include enhancing data quality and ensuring that core data assets – such as real-world data, adverse event reports, and medicinal product master data – are catalogued and made interoperable across the EU regulatory system. A cornerstone of this is the further roll-out of the Product Management System (PMS), which will act as the central source of product master data for all EU medicinal products. The workplan marks the beginning of a transition towards data-driven regulation within the EU. This will require companies to assess their data strategies, governance models and readiness to support regulatory processes that increasingly rely on sophisticated analytics and digital technologies. Early alignment with these regulatory priorities will be important for ensuring future compliance, fostering smoother regulatory engagement, and positioning organisations to benefit from more transparent and efficient regulatory pathways.

Authored by Hein van den Bos, Julia Mischie and Milan Tuijp.