Scientific guidance on post-authorisation efficacy studies - Scientific guideline
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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
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Overview of comments received on draft scientific guidance on post-authorisation efficacy studies - First version (PDF/787.83 KB)
First published: 20/12/2016
Last updated: 20/12/2016 -
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Draft scientific guidance on post-authorisation efficacy studies - First version (PDF/202.08 KB)
Draft: consultation closed
First published: 06/11/2015
Last updated: 06/11/2015
Consultation dates: 06/11/2015 to 31/01/2016
EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015