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EMA: Q&A Documents on Centralised Procedures updated (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)

The Questions & Answers (Q&A) documents relating to centralised marketing authorisation procedures, last revised in June, have now been updated and published on the European Medicines Agency (EMA) website. These Q&As are intended to provide guidance and guidelines for marketing authorisation holders and applicants of centralised procedures and provide answers to potential questions at different stages of the centralised marketing authorisation application process.

The new versions of the “Q&A” documents for central procedures can be found at:

Topics before and during application

Topics after marketing authorisation has been granted

See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). EMA: Q&A Documents on Centralised Procedures updated (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 12 janvier 2026 à l’adresse https://doi.org/10.58079/o67j


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