EMA Updates Q&A on Centralized Marketing Authorization Procedures

In December 2025, the European Medicines Agency (EMA) released a revised version of its “Questions & Answers (Q&A)” guidance covering centralized marketing authorization procedures. The updated document is available on the agency’s website.

The section titled “European Medicines Agency pre-authorization procedural advice for users of the centralized procedure” has been expanded and refined. In Chapter 2, which outlines steps prior to application submission, subsection 2.4 has been revised, particularly Question 2.4.2 concerning the appointment of (Co-)Rapporteurs and their assessment teams across different procedure types.

In Chapter 5 on application assessment, additional clarification has been added to Question 5.1.1 regarding evaluation timelines. The update includes further details on timetable calculations, including specific considerations for advanced therapy medicinal products requiring consultation with the Committee for Advanced Therapies (CAT). Minor editorial corrections were also introduced.

The updated Q&A document is accessible via the EMA website.

15-02-2026