Assessment of cardiovascular safety profile of medicinal products - Scientific guideline

This document provides recommendations for the evaluation of the cardiovascular safety profile of new, non-generic medicinal products that are intended for long-term treatment of cardiovascular and metabolic diseases.

Keywords: Cardiovascular safety, cardiovascular outcome study (CVOT), major cardiovascular event (MACE), cardiovascular and metabolic disease, diabetes, obesity, hypertension, hypercholesterolaemia

Current effective version

Reflection paper on assessment of cardiovascular safety profile of medicinal products

AdoptedReference Number: EMA/CHMP/50549/2015Summary:

The purpose of this reflection paper is to provide recommendations for the evaluation of the cardiovascular safety profile of new (non-generic, non-biosimilar) medicinal products that are intended for long-term treatment of certain cardiovascular and metabolic diseases (see section 3).

Document history

Overview of comments received on 'Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases’

Reference Number: EMA/754705/2015

Reflection paper on assessment of cardiovascular risk of medicinal products for the treatment of cardiovascular and metabolic diseases

Draft: consultation closedConsultation dates: 12/06/2015 to 30/09/2015Reference Number: EMA/CHMP/50549/2015Summary:

The purpose of this reflection paper is to provide recommendations for the evaluation of the cardiovascular safety profile of new, non-generic medicinal products that are intended for long-term treatment of cardiovascular and metabolic diseases. It aims to clarify the requirements for these products at the time of marketing authorisation with respect to data needed for the evaluation and quantification of the cardiovascular safety profile.