Regulatory information – EMA improves its guidance for post-authorisation activities
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 pre-submission checklist for type II variation applications 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.