This document is a practical roadmap for how the EU medicines network intends to strengthen data interoperability, analytics, and AI-enabled regulatory capabilities, with annual updates planned. For pharmaceutical companies, it signals where regulators are investing: DARWIN EU (RWE), more systematic clinical study data analytics, AI governance and tools, and interoperability standards aligned with EHDS.
Notably, the workplan outlines the following focus areas and deliverables:
- A clear long-term vision: “Trusted medicines by unlocking the value of data”, with an explicit commitment to using data within an ethical framework and in compliance with EU data legislation.
- A structured program across six workstreams: Strategy & governance; Data analytics; Artificial intelligence; Data interoperability; Stakeholder engagement & change management; Guidance & international initiatives.
- Alignment with major EU initiatives impacting data exchange and evidence generation, including European Health Data Space (EHDS/TEHDAS2), revised EU pharmaceutical legislation, IDMP-related work (UNIWIDE IDMP), and broader interoperability frameworks.
- Scaling Real-World Evidence via DARWIN EU, including onboarding data partners, executing studies, and planning further expansion (DARWIN EU 2).
- Transitioning clinical study data activities from pilots toward systematic submission and analysis of patient-level clinical study data for centrally authorised products (CAPs), supported by tools/process updates and training.
- An AI workstream that includes: publishing Guiding Principles for Good AI Practice, an AI glossary, annual AI Observatory updates, AI literacy training (linked to AI Act obligations), and deployment of internal AI tools (e.g., Scientific Explorer, SPC Reader/SPC Search, AI assistants) supported by an AI Tools Framework.
- Interoperability deliverables such as data catalogues/metadata management, defined data roles (e.g., trustees/stewards), and a medicines-regulation data glossary—explicitly linked to EHDS readiness.
Workplan PDF (EMA): https://www.ema.euro … es-regulation_en.pdf
Work plan PDF (EMA): https://www.ema.euro … working-group_en.pdf