The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) have released a new workplan outlining their vision for integrating data and artificial intelligence into the medicines regulatory lifecycle by 2028.
The objective is to harness the potential of regulatory and health data — including real-world evidence, genomics, and AI/ML tools — to support faster, smarter, and safer decision-making across the European medicines regulatory network.
Key points from the workplan include:
- A focus on data interoperability, sharing, and governance across the EU
- Alignment with major legislative initiatives such as:
- The European Health Data Space (EHDS)
- The AI Act
- The Interoperable Europe Act
- The upcoming pharmaceutical legislation reform
- A strong emphasis on ethical standards, data privacy, and cybersecurity
While the workplan sets a clear strategic direction, the accompanying article — “Leveraging the power of data for public and animal health” — provides more of a high-level overview than detailed, actionable steps.
It will be important to follow how this vision translates into concrete measures, timelines, and measurable outcomes as the role of AI in health continues to evolve.
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