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
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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