EMA Guide Outlines Steps Taken by Multinational Review Team Leaders

The European Medicines Agency published an internal guide on the use of multinational assessment teams for pre-authorization reviews and post-authorization extensions for new medicines.

As part of a cross-border initiative for pre-authorization reviews introduced four years ago, the EMA began forming assessment teams consisting of members from different European national regulatory authorities.

The process was formalized across the European Union in 2015 to include initial marketing applications and coordination of scientific advice procedures. In April, it was expanded to cover post-authorization extensions of indications.