Clinical investigation of medicinal products in the treatment of lipid disorders - Scientific guideline

This 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.

Keywords: Lipid lowering agents, cholesterol, hypercholesterolemia, statins

Current effective version

Guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 3

Adopted Reference Number: EMA/CHMP/748108/2013 Rev. 3 Legal effective date: 01/01/2017 Summary:

This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders.

Document history - Revision 3 (current version)

Guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 3

Adopted Reference Number: EMA/CHMP/748108/2013 Rev. 3 Legal effective date: 01/01/2017 Summary:

This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders.

Document history - Revision 1 and 2

Guideline on clinical investigation of medicinal products in the treatment of lipid disorders

Adopted Reference Number: EMA/CHMP/748108/2013

Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders

Reference Number: EMA/CHMP/748246/2013

Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 1 and 2

Draft: consultation closed Consultation dates: 15/12/2012 to 15/03/2013 Reference Number: EMA/CHMP/718840/2012 Summary:

This document is the revised version of the existing guidance note (CHMP/EWP/3020/03) on lipid-modifying agents. The guideline is intended to provide guidance for the evaluation of medicines in the treatment of lipid disorders and details the main regulatory requirements that are expected to be followed in the development of a lipid-modifying medicinal product.

Draft guideline on lipid lowering agents - Revision 1

Draft: consultation closed Consultation dates: 18/11/2010 to 31/05/2011 Reference Number: EMA/CPMP/3020/2003 Summary:

This addendum replaces some chapters of the NfG on lipid lowering agents (CPMP/EWP/3020/03).

Concept paper on the need to update the note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders and the note for guidance on the clinical investigation on hypertension - Revision 4

Reference Number: EMEA/CHMP/EWP/350495/2009

Concept paper on the need for the development of a paediatric addendum to the chmp note for guidance on the clinical investigation of medicinal products in the treatment of lipid disorders

Reference Number: EMEA/CHMP/EWP/7895/2009

Document history - First version

Note for guidance on clinical investigation of medical products in the treatment of lipid disorders

Adopted Reference Number: CPMP/EWP/3020/03 Legal effective date: 01/01/2005

Concept paper on the development of a committee for proprietary medicinal products (CPMP) note for guidance on the evaluation of medicinal products for the treatment of dyslipoproteinaemia

Reference Number: CPMP/EWP/512/01