Date
Location
The European Medicines Agency (EMA) will host the 15th industry stakeholder platform on the operation of the centralised procedure for human medicines on 28 November 2025. This meeting continues the series of regular exchanges between regulators and representatives of industry stakeholder organisations, aiming to foster constructive dialogue on both general updates and focused discussions to support continuous improvement.
This session will focus on the implementation of the classification guideline on variations, the integration of patient experience data, and ongoing initiatives related to the centralised procedure. There will be updates on the focus group addressing submission predictability and the REVAMP process, as well as progress on IRIS, the electronic Application Form (eAF), and the optional submission of CTD 4.0 in the centralised procedure.
Additionally, the meeting will discuss the implementation of the SEND proof of concept study, provide an update from the Cancer Medicines Pathfinder industry focus group, and review EMA activities and regulatory challenges related to the Instrument for Pre-accession Assistance (IPA). The agenda also includes an update on the review of the QRD template.