Scientific guidance on post-authorisation efficacy studies - Scientific guideline

This guidance has been developed in accordance with Article 108a of Directive 2001/83/EC which provides a mandate for European Medicines Agency (EMA) in cooperation with competent authorities and other interested parties to draw up scientific guidance on PAES.

Keywords: Post-authorisation efficacy studies (PAES), efficacy, observational, randomised, trials pragmatic, explanatory, historical controls

Current effective version

Scientific guidance on post-authorisation efficacy studies - First version

Adopted Reference Number: EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015 Legal effective date: 01/06/2017

Document history

Overview of comments received on draft scientific guidance on post-authorisation efficacy studies - First version

Draft scientific guidance on post-authorisation efficacy studies - First version

Draft: consultation closed Consultation dates: 06/11/2015 to 31/01/2016 Reference Number: EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015 Summary:

This guidance is intended to provide scientific guidance for marketing-authorisation holders and national competent authorities on post-authorisation efficacy studies with regard to methodological considerations and the potential role of particular study designs. This guidance does not include procedural aspects, which are dealt with in the human post-marketing authorisation regulatory and procedural guidance.