Clinical investigation of medicinal products in the treatment of lipid disorders

Current effective version

PDF iconRevision 3 - Adopted guideline

Reference numberEMA/CHMP/748108/2013 Rev. 3
Published08/07/2016
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

PDF iconAdopted guideline

Published: 08/07/2016

Revision 1 and 2

PDF iconAdopted guideline

PDF iconOverview of comments

PDF iconDraft guideline (Rev. 1 and 2)

PDF iconDraft guideline (Rev. 1)

PDF iconConcept 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

PDF iconAdopted guideline

PDF iconConcept paper

In operation: 01/01/2005–31/05/2014

Published: 21/05/2001


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