EMA NDSG Work Plan: Inside the Network Data Steering Group Workplan 2025–2028

In an era where data drives decisions and innovation defines progress, the European Medicines Agency (EMA) and Heads of Medicines Agencies (HMA) have launched an ambitious strategy to transform medicines regulation through data and digital technologies. At the heart of this transformation lies the Network Data Steering Group (NDSG) Workplan 2025–2028 — a comprehensive roadmap aimed at unleashing the full value of data for the benefit of public and animal health in the European Union.

The NDSG’s guiding vision is clear and powerful: “Trusted medicines by unlocking the value of data.” The plan aligns closely with the overarching European Medicines Agencies Network (EMAN) strategy and focuses on ethical, secure, and interoperable data usage.

The workplan is divided into six key workstreams:

• Strategy and governance

• Data analytics

• Artificial intelligence (AI)

• Data interoperability

• Stakeholder engagement and change management

• Guidance and international initiatives

• Strategy and Governance

  The NDSG is developing a coordinated approach to data management, standardization, and analytics. Major deliverables include the EMRN (European Medicines Regulatory Network) data strategy, analytic strategy, and standardization strategy, all designed to ensure high-quality, shareable data assets. The workplan also supports the rollout of new EU pharmaceutical legislation, the European Health Data Space (EHDS2), and the Interoperable Europe Act, ensuring preparedness for upcoming regulatory changes.

• Data Analytics

  The NDSG is reviewing advanced methodologies and new data types to enhance evidence generation. This includes leveraging real-world data through the operational DARWIN EU® network, piloting access to individual patient data from clinical trials, and improving pharmacovigilance signal detection. There’s a strong emphasis on integrating innovative sources like genomic data, synthetic data, digital twins, and patient experience data into regulatory decision-making.

• Artificial Intelligence

  AI is being positioned as a core tool for regulatory science. The workplan covers guidance, policy, and experimentation with AI-driven methodologies, including novel clinical trial designs and advanced analytics for patient evaluation. The NDSG aims to foster collaboration, develop new tools, and manage change as AI becomes increasingly embedded in regulatory processes.

• Data Interoperability

  Ensuring that data can be easily discovered, catalogued, and shared is a top priority. The workplan addresses data quality management, organizational and semantic interoperability, and the development of best practices for impact assessments. These efforts will support seamless data exchange across the European regulatory network.

• Stakeholder Engagement and Change Management

  Change management is central to the NDSG’s agenda. The group is rolling out strategies to upskill the network, engage stakeholders, and communicate the benefits of data-driven regulation. Workshops, multistakeholder forums, and ongoing support for change are planned throughout the workplan’s lifecycle.

• Guidance and International Initiatives

  The NDSG is committed to developing guidance documents and participating in international projects to ensure the EU remains at the forefront of global regulatory science. This includes supporting projects like TEHDAS2, QUANTUM, and harmonizing with international standards.

Key Milestones and Deliverables (2025–2028)

Workstream	2025–2026 Highlights	2027–2028 Highlights
Strategy & Governance	Finalize and publish EMRN data strategies; support EHDS2 and new pharma legislation; annual workplan updates	Monitor implementation; support rollout of analytics capabilities; horizon scanning for new data/tools
Data Analytics	DARWIN EU® studies; clinical study data pilot; review of biostatistics, modeling, synthetic data, AI analytics	Launch Enhanced ADR public website; publish experience reports; integrate new data types like mHealth and social media
Artificial Intelligence	Guidance and experimentation with AI tools; develop policy support	Expand AI use in regulatory science; share learnings from pilot projects
Data Interoperability	Develop interoperability glossary; support Interoperable Europe Act	Share best practices; monitor impact assessments
Stakeholder Engagement	Change management strategies; stakeholder workshops	Multistakeholder workshops; ongoing training
Guidance & International	Support QUANTUM, TEHDAS2, and public consultations	Continue international alignment and guidance updates

The NDSG Workplan 2025–2028 represents a bold and comprehensive strategy to reshape how the EU regulates medicines. From data governance to AI ethics, and from real-world evidence to stakeholder engagement, the roadmap lays the foundation for a smarter, more agile regulatory future.

For full details, click this LINK.