EU To Simplify ‘Increasingly Complex’ Post-Authorization Variation Procedures

Reclassifying certain variations and having more flexibility on the level of technical information required in submissions are among ideas put forward by the European Commission in its latest consultation.

Line from A straight to the point B. The concept of simplify — The EU is to simplify processes for making changes to marketing authorizations • Source: Shutterstock

The European Commission has drawn up plans to reduce the administrative burden on pharma firms and regulatory authorities caused by the growing number of applications for variations to marketing authorizations (MAs).

The proposals, which would streamline the current framework and speed up the handling of variation applications, have just been...