EMA – Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held on 28 November 2025: presentation materials are now available
The 15th industry stakeholder platform on the operation of the centralised procedure for human medicines 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 focused on the implementation of the classification guideline on variations, the integration of patient experience data, and ongoing initiatives related to the centralised procedure. There were 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 discussed the implementation of the SEND proof of concept study, provided an update from the Cancer Medicines Pathfinder industry focus group, and reviewed EMA activities and regulatory challenges related to the Instrument for Pre-accession Assistance (IPA). The agenda also included an update on the review of the QRD template.
More information on this event on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 décembre 2025). EMA – Fifteenth meeting of the industry stakeholder platform on the operation of the centralised procedure for human medicines held on 28 November 2025: presentation materials are now available. ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/15bv8





