EMA – Publication of the presentation materials of the Thirteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held the 22 November 2024

This meeting focused on: transitional measures to implement the new variation regulation; ePI pilots readout, learnings and next steps; focus group on cancer medicines pathfinder regulatory interactions. The meeting also informed on and discussed the following: Ongoing initiatives on the centralised procedure Dynamic regulatory assessment Lifecycle management of combination products at post-authorisation Clinical study data pilot Public consultation to review the QRD template for product in...