Clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia - Scientific guideline

This document provides guidance on the clinical evaluation of medicinal products intended for the treatment of chronic immune thrombocytopenia.

Keywords: Chronic primary immune thrombocytopenia, thrombopoietin receptor agonists

Current effective version

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

Adopted Reference Number: EMA/CHMP/153191/2013

Document history

Overview of comments received on “Guideline on the clinical development of medicinal products intended for the treatment of chronic primary immune thrombocytopenia”

Reference Number: EMA/652909/2013

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

Draft: consultation closed Consultation dates: 20/03/2013 to 31/08/2013 Reference Number: EMA/CHMP/153191/2013 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.