Draft scientific guidance on post-authorisation efficacy studies

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Download document Draft scientific guidance on post-authorisation efficacy studies
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
Email address for submissions paesconsultation@ema.europa.eu

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.