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

News 14/07/2017

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:

How useful was this page?

Add your rating