EMA Updates Q&A Guidance on Centralised Authorisation Procedures

In October 2025, the European Medicines Agency (EMA) released an updated version of its Questions & Answers (Q&A) document for centralised authorisation procedures. The revisions focus on clarifying requirements before and during the application process.

Key Updates in Chapter 3: Preparing the Dossier
Several answers related to the Risk Management Plan (RMP) have been updated, including:

• 3.5.6: Guidance on the correct template for RMP submissions
• 3.5.7: Details on when and how the full RMP will be published
• 3.5.13: Information on how RMPs are assessed
• 3.5.14: Rules on submitting an updated RMP after CHMP opinion to reflect last-minute changes

Updates in Chapter 5: Assessment of the Application
The answer to 5.1.11, addressing whether EMA assessment or inspection documents may be shared with regulators outside the EU, now includes a recommendation to use a specific template to support such information sharing.

The newly revised Q&A document is available under the section Issues before and during the application process on the EMA website.

01-12-2025