Last updated: 6 November 2025
To view updates, click on the ‘+’ sign below.
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
The document with the above title has been updated and republished (28 October 2025). You can view it here.
There are updates to the following sections in Sep-Oct 2025:
- 1.6. What will be the legal basis for my application?
- 2.4. What is the procedure for appointment of Rapporteurs/Co-Rapporteurs and their assessment teams?
- 2.7. How should I notify a change in the contact person and/or intended submission date of my application?
- 3.5.6. What template should I use for the RMP submission? Rev. Oct 2025
- 3.5.7. When and how will the full RMP be published?
- 3.5.11. How is the assessment of an educational program as additional risk minimisation handled?
- 3.5.13. How will my RMP be reviewed?
- 3.5.14. Can I submit after the opinion a version of the RMP to reflect the last-minute changes made during the CHMP?
- 5.1.11. Can EMA assessment or inspection documents be shared with regulators outside the EU?
Member states contact points for translations review
Version 6.9 (Nov 1 2025) of the guidance with the above title has been published. You can view it here.
eCTD v4.0 – EU Controlled Vocabularies v3 now available
A new version of the EU eCTD v4.0 controlled vocabularies (v3) is now available, in both MS Excel (.xlsx) and genericode (.xml) formats.
- The changes compared to the previous version are highlighted in the MS Excel document, and marked with new/updated, accordingly.
- Please note that previous versions of the EU controlled vocabularies are still valid.
Source: eSubmission