EMA releases the NDSG Workplan 2026–2028 on Data and AI in medicines regulation

The workplan marks a significant step forward in embedding innovative methodologies into regulatory science. Of particular relevance is the explicit recognition of modelling and simulation (M&S) as a key component among emerging data types and approaches for evidence generation. This reflects a growing commitment at EU level to leverage data-driven and AI-enabled methodologies in supporting regulatory decision-making.

A central priority in the workplan is the development of guidance on artificial intelligence for clinical development and pharmacovigilance. This initiative will be accompanied by a dedicated roadmap aligned with the forthcoming EU Biotech Act, with the aim of equipping experts and assessors across the network with the necessary frameworks and tools to evaluate AI-driven methodologies.

👉 Access the full workplan

👉 Learn more about the Network Data Steering Group (NDSG)