Assuring the EU regulatory network’s sustainability is key to the functioning of the EU regulatory system. The frequent changes to intended submission dates for initial marketing applications of medicinal products via the centralised procedure pathway, as well as the unpredictability of post-marketing submissions, have a substantial impact on the resources planning within the EU regulatory network and create extra pressure within the system.

The European Medicines Agency (EMA) facilitates this information day with the aim to enhance a common understanding, raise awareness of the challenges for the EU regulatory network and to share best practices for planning and preparing submissions, as well as communicating changes.

Ample time is foreseen for Q&A. The faculty invites participants to submit related questions by 17 November 2025 latest. Submit your questions to emaevents@diaglobal.org.