HMA-EMA Network Data Steering Group Releases Workplan

The joint HMA-EMA Network Data Steering Group published its 2025–2028 workplan in May 2025 to optimise use of data and artificial intelligence across EU medicines regulation. The plan prioritises strengthening analytics capabilities, expanding the DARWIN EU coordination centre, and advancing EMA's Product Management Service to improve evidence generation. The workplan aims to support regulatory decision-making and speed patient access to safe, effective medicines.
Key Points
- 1Publishes 2025–2028 workplan to optimise data use and AI across EU medicines regulation.
- 2Targets stronger analytics, DARWIN EU expansion, and product master data integration to fill evidence gaps.
- 3Enables regulators and practitioners to generate higher-quality evidence and speed patient access to medicines.
Scoring Rationale
Official EU workplan provides strong regulatory data and AI roadmap, but is strategic guidance rather than immediate technical innovation.
Sources
Public references used for this report.
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