Draft concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

  • Email
  • Help

Document details

Download document Draft concept paper on the need for revision of the guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease
Reference number EMA/CHMP/281099/2013
Status draft: consultation open
First published 03/06/2013
Last updated 03/06/2013
Consultation start date 03/06/2013
Consultation end date 01/09/2013
Email address for submissions cvswpsecretariat@ema.europa.eu

Summary

Since the publication of the European Medicines Agency guidance on the clinical investigation of medicinal products for the treatment of venous thromboembolic disease in 2000, there has been intense research in this field. An update of this guideline is considered necessary to adapt its content to current scientific knowledge and to harmonise it with the content of new or revised Agency guidelines related to clinical investigation with antithrombotics.