Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia

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Download document Draft guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia
Reference number EMA/CHMP/153191/2013
Status draft: consultation open
First published 20/03/2013
Last updated 20/03/2013
Consultation start date 20/03/2013
Consultation end date 31/08/2013
Email address for submissions oncwpsecretariat@ema.europa.eu

Summary

This guideline describes the information on the clinical development to be documented when an application for a marketing authorisation for a medicinal product is made for the treatment of chronic primary immune thrombocytopenia. The purpose of this guidance is to provide a harmonised regulatory approach that will lead to a consistent assessment of products by regulators and set clear standards for industry.