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.

 

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

Posted on the EMA website on 20 March 2013