Assuring the EU regulatory network’s sustainability is key to the functioning of the EU regulatory system. This workshop brings together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it can be improved. The frequent changes to intended submission dates for initial marketing applications, 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.

This multi-stakeholder workshop brings together all relevant parties to facilitate a common understanding, raise awareness of the problem and to share best practices for planning and preparing submissions, as well as communicating changes. It highlights case studies from all parties, each facing different challenges, and provides a platform for jointly discussing and identifying areas for improvement.

The objectives of this workshop are: 

• to showcase data and trends on submissions predictability – problem statement,
• to share best practices approach for submission of initial marketing authorisation applications,
• to create awareness of the impact from a resource perspective when changing submission dates,
• to strengthen cooperation and communication amongst stakeholders,
• to discuss strategies to improve submission predictability.