Scientific guidance on post-authorisation efficacy studies

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Current effective version

Adopted guideline

Reference numberEMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015
Effective from01/06/2017
KeywordsPost-authorisation efficacy studies (PAES), efficacy, observational, randomised, trials pragmatic, explanatory, historical controls
DescriptionThis 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.

Document history

First version
Current version


Adopted guideline


Overview of comments


Draft guideline

In operation: 01/06/2017-present


Published: 20/12/2016


Published: 06/11/2015

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