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

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Document details

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 closed
First published 2013-03-20
Last updated 2013-03-20

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.