EMA – Joint HMA/EMA multi-stakeholder workshop on submission predictability – 25 September 2024: publication of the event’s report and materials

On 25 September 2024, the EMA and the HMA held a joint workshop on submission predictability, bringing together representatives from the national competent authorities, industry, and EMA, to focus on submission predictability and how it can be improved and which objectives were to:

• 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.

The presentation materials, the video recording as well as the report of the event are now available on the EMA Website.