As the European Union (EU) continues its digital health transformation, the European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have published a joint 2025-2028 work plan (the Workplan) to enhance the use of data and artificial intelligence (AI) across the European Medicines Regulatory Network (EMRN).
The joint EMA/HMA group established to implement the Workplan, the Network Data Steering Group (NDSG), will support the vision of “trusted medicines by unlocking the value of data.” The Workplan sets out high-level objectives to improve how data are accessed, shared and analysed to facilitate efficient decision-making for both human and veterinary medicines.
A Strategic Framework with Six Pillars
The Workplan is structured around six key pillars:
- Strategy and Governance – Establishing a coordinated approach to data management and aligning with major EU legislative initiatives, including the European Health Data Space (EHDS), the Interoperable Europe Act and new EU pharmaceutical legislation.
- Data Analytics – Enhancing the use of real-world data, clinical trial data and emerging data types (e.g. genomic and patient-reported data) to support evidence generation and regulatory decisions.
- Artificial Intelligence – Promoting the safe, ethical and effective use of AI in medicines regulation, including compliance with the EU AI Act and the development of shared tools, guidance and training.
- Data Interoperability – Improving the discoverability, quality and standardisation of health data across the EU, ensuring it can be used consistently and effectively across systems and borders.
- Stakeholder Engagement and Change Management – Supporting the EMRN and its stakeholders through training, communication and change management strategies to build a data-driven regulatory culture.
- Guidance and International Initiatives – Contributing to the development of EU and international standards and methodologies, particularly in areas such as real-world evidence and model-informed drug development.
Although the Workplan is not legally binding, it is a key strategic document that supports the EU's broader digital health agenda. It aligns with major legislative initiatives such as the European Health Data Space and the EU AI Act, and outlines how data and AI can be used in medicines regulation. Clients operating in the life sciences and healthcare sectors should be aware of the regulatory priorities and future expectations around data use, interoperability and AI compliance that are set out in the Workplan.
Contributed by Louisa Muldowney, Molly Kennedy.
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