Post-authorisation efficacy studies: questions and answers
This page lists questions that marketing-authorisation holders (MAHs) may have on post-authorisation efficacy studies (PAESs). It provides an overview of the European Medicines Agency's (EMA) position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. Revised topics are marked 'New' or 'Rev.' upon publication.
A PDF version of the entire post-authorisation guidance is available:
- European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
These questions and answers have been produced for guidance only and should be read in conjunction with the rules governing medicinal products in the European Union, volume 2, notice to applicants.
MAHs must in all cases comply with the requirements of Community legislation. Provisions that extend to Iceland, Liechtenstein and Norway by virtue of the European Economic Area agreement are outlined in the relevant sections of the text.
Scientific guidance on PAES
EMA has developed, in cooperation with national competent authorities and other interested parties, a draft scientific guideline on PAES which outlines how companies should design these studies in order to support regulatory decision making in the European Union: