Earlier today (04-November-2022) the European Medicines Agency (EMA) released updated guidance on "Pre-Authorisation Procedural Advice for Users of the Centralised Procedure" and "Post-Authorisation Procedural Advice for Users of the Centralised Procedure".
Under the centralised authorisation procedure, pharmaceutical companies submit a single marketing-authorization application to EMA.
The purpose of this guidance document is to answer questions that users of the centralised procedure may have and to provide an overview of the EMA's position on issues, which are typically discussed during pre-submission meetings.
A pre-submission meeting, which should take place approximately 7 months before the anticipated date of submission of the application, is an important opportunity for applicants to obtain legal, regulatory, and procedural advice from the EMA.
By following the guidance information and arranging pre-submission meetings, applicants will be able to submit applications in compliance with the legal and regulatory requirements and which can be validated quickly
Pre-submission meetings between applicants and the EMA/(Co-)Rapporteur are highly recommended by the EMA.
This guidance provides an overview of the Agency’s position on issues, which are typically addressed in discussions or meetings with MAHs in the post-authorisation phase.
The guidance information and pre-submission dialogue between MAHs and the Agency will help MAHs submit applications that are compliant with legal and regulatory requirements and that can be validated and processed quickly.
To enable optimal planning, identify procedural issues and handle overlapping applications, MAHs should inform the Agency and (Co-) Rapporteur of all upcoming post-authorisation submissions for the next 6-12 months.