Clinical investigation of medicinal products in the treatment of lipid disorders

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Current effective version

Revision 3 - Adopted guideline

Reference numberEMA/CHMP/748108/2013 Rev. 3
Effective from01/01/2017
KeywordsLipid lowering agents, cholesterol, hypercholesterolemia, statins
DescriptionThis document provides guidance on the evaluation of drugs in the treatment of lipid disorders. It details the main regulatory requirements that are expected to be followed in the development of a lipid modifying medicinal product.

Document history

Revision 3

Current version

Adopted guideline

Published: 08/07/2016

Revision 1 and 2

Adopted guideline


Overview of comments


Draft guideline (Rev. 1 and 2)


Draft guideline (Rev. 1)


Concept paper (Rev. 2)


Concept paper (Rev. 1)

In operation: 01/06/2014–31/12/2016


Published: 16/01/2014


Published: 14/12/2012


Published: 21/12/2010


Published: 23/07/2009


Published: 30/05/2008

First version

Adopted guideline


Concept paper 

In operation: 01/01/2005–31/05/2014


Published: 21/05/2001

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