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:
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:
- Draft scientific guidance on post-authorisation efficacy studies
- 1. What is a PAES imposed in accordance with the Commission Delegated Regulation?
- 2. How and where the PAES imposed in accordance with the Commission Delegated Regulation will be reflected in the marketing authorisation?
- 3. Following which procedure will my imposed PAES protocol be assessed?
- 4. When should I submit my imposed PAES protocol?
- 5. In which timeframe will my imposed PAES protocol be evaluated (timetable)?
- 6. What are the possible outcomes of the evaluation of an imposed PAES protocol?
- 7. Do I have to submit interim results?
- 8. Do I have to submit the final results of my imposed PAES?
- 9. Do I have to pay fees for the protocol and final study results submission?
- 10. How is a PAES enforced?
- 11. Will there be any publication on the outcome of my PAES protocol and final study results assessment?
- 12. Who should I contact if I have a question when preparing my application?