This guidance is intended to provide scientific guidance for marketing-authorisation holders and national competent authorities on post-authorisation efficacyEMA 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.
Go to: EMA Draft Scientific Guidance on Post-Authorisation Efficacy Studies (06-Nov-2015)

Reference number EMA/PDCO/CAT/CMDh/PRAC/CHMP/261500/2015
Status draft: consultation open
First published 06/11/2015
Last updated 06/11/2015
Consultation start date 06/11/2015
Consultation end date 31/01/2016

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