The European Medicines Agency's joint Network Data Steering Group (NDSG) discussed updates on European Commission initiatives including the Biotech Act proposal and the Apply AI strategy, as well as progress on artificial intelligence guidance and real-world evidence reporting, during a meeting on 16 June 2026. The meeting, chaired by EMA's Peter Arlett, brought together representatives from national competent authorities, the European Commission, and other stakeholders to coordinate data-related activities across the EU medicines regulatory network.
On EC initiatives, Vaia Apostolidou and Yiannos Tolias presented the BioTech Act proposal and its potential impact on AI, alongside information on the Apply AI strategy. The group discussed the implications for regulatory science and data governance. Regarding AI guidance, Luis Pinheiro, Kristin Karlsson, and Julie Durand outlined a mandate for a governance group to develop further AI guidance, an overview of planned guidance, and an industry survey on the scope of AI guidance in pharmacovigilance. The group was asked to endorse the governance group's mandate and discuss the survey results. In international collaboration, Luis Pinheiro reported on activities including FDA/EMA terminology harmonisation on AI, a proposed ICH topic, publication of AI research priorities and the 2025 Observatory report, and the IncreaseNet collaboration.
The meeting also covered the publication of the Real-World Evidence (RWE) annual report, including an update on change management activities, presented by Alexandra Pacurariu. The draft agenda and minutes from the previous meeting were adopted, with the May minutes finalised post-meeting. The NDSG, a joint body between EMA and the Heads of Medicines Agencies, coordinates the European medicines regulatory network's approach to data-driven regulation, including real-world evidence, AI, and digital tools.