Improvement of EMA’s guidance on post-authorization activities

The best practice guidelines and support documents for marketing authorization holders (MAHs) have been updated by EMA. The amendments involve topics concerning type II variations, post-authorization safety studies (PASS) and changes related to quality aspects.
The most important updates are:

• A new pre-submission checklist for type II variation applications. This validation checklist will help applicants to submit complete and correct type II variation packages.
• An updated Q&A for PASS with 15 new questions and answers. This Q&A includes detailed information on submission requirements, assessment and implementation of outcomes for protocols, protocol amendments and final study reports of non-interventional imposed PASS.

An update of the ‘Classification of post-authorization changes – Quality aspects’. Eight new Q&As to advise MAHs on post-authorization procedures, including additional variation classification categories.