EMA – Revision of the EMA pre-authorisation procedural advice for users of the centralised procedure
The EMA published its last version of the pre-authorisation procedural advice for users of the centralised procedure.
These questions and answers (Q&As) provide an overview of the European Medicines Agency’s (EMA) advice on issues that are typically addressed in discussions or meetings with marketing authorisation holders in the application phase.
More specifically, the EMA revised the three following questions:
- Can I apply for Design Space or Process Analytical Technology (PAT) in my application?
- When do I have to submit an Environmental Risk Assessment (ERA)?
- When can I expect a pre-approval GCP inspection and how are they conducted?
This Q&A is available directly on the EMA Website.
OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (8 novembre 2024). EMA – Revision of the EMA pre-authorisation procedural advice for users of the centralised procedure. ELSIBI. Consulté le 19 janvier 2025 à l’adresse https://doi.org/10.58079/12nc0
