Regulatory information – EMA improves its guidance for post-authorisation activities

14 July 2017

Updated areas: Type II variations, post-authorisation safety studies and quality variations

The European Medicines Agency (EMA) has updated its best practice guidelines and support documents for marketing authorisation holders (MAHs) in the areas of type II variations, post-authorisation safety studies and changes related to quality aspects.

The main aim is to improve the quality of post-authorisation applications by better assisting applicants in complying with the legal and regulatory requirements and avoiding frequent mistakes. This will result in a more efficient validation process. The guidance documents are part of EMA's commitment to operational excellence.

The main updates are:

• a new to help applicants verify that they have completed all the necessary requirements before submitting the application;
• an updated questions-and-answers for post-authorisation safety studies (PASS) with 15 new questions and answers to provide marketing-authorisation holders with detailed information on the 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-authorisation changes - Quality aspects' with eight new questions and answers providing advice to MAHs on the classification of changes to the marketing authorisation post-authorisation and certain variation classification categories.