EMA Updates Q&A for Centralized Authorization Procedures

In December 2025, the European Medicines Agency (EMA) published an updated version of its Questions & Answers (Q&A) document on centralized authorization procedures. The guidance provides clarifications for applicants before and during the submission of a centralized procedure.

Key updates include:

• Chapter 2 – Steps prior to submission: The procedure for appointing Rapporteurs and Co-Rapporteurs and their assessment teams has been revised, notably in question 2.4.2 on appointments for different application types.
• Chapter 5 – Assessment of the application: Question 5.1.1 on evaluation timelines was supplemented with guidance on timetable calculation, including specific considerations for advanced therapy medicinal products (ATMPs) requiring CHMP consultation with CAT. Minor formal edits and corrections were also made.

The updated Q&A document is available on the EMA website under:

• Topics before and during the application process

31-01-2026