Clinical investigation of medicinal products for the treatment of venous thromboembolic disease - Scientific guideline

This document provides guidance on the clinical development of new medicinal products intended for the treatmenr of venous thromboembolism.

Keywords: Venous thromboembolism, deep vein thrombosis, pulmonary embolism, guidelines, anticoagulant

Current effective version

Guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Adopted Reference Number: EMA/CHMP/41230/2015 Summary:

Venous thromboembolism (VTE) is the third leading cause of death due to circulatory diseases, only behind of myocardial infarction and stroke.

Document history

Overview of comments received on 'Draft guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease'

Reference Number: EMA/129183/2016

Draft guideline on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Draft: consultation closed Consultation dates: 01/04/2015 to 30/09/2015 Reference Number: EMA/CHMP/41230/2015 Summary:

Venous thromboembolism (VTE) is the third leading cause of death due to circulatory diseases, only behind of myocardial infarction and stroke.

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

Draft: consultation closed Consultation dates: 03/06/2013 to 01/09/2013 Reference Number: EMA/CHMP/281099/2013 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.

Note for guidance on clinical investigation of medicinal products for the treatment of venous thromboembolic disease

Adopted Reference Number: CPMP/EWP/563/98 Legal effective date: 01/06/2000