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
This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders.
English (EN) (203.77 KB - PDF)
Document history - Revision 3 (current version)
Guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 3
This document is the revised version of the ‘Note for guidance on clinical investigation of medicinal products in the treatment of lipid disorders.
English (EN) (203.77 KB - PDF)
Document history - Revision 1 and 2
Guideline on clinical investigation of medicinal products in the treatment of lipid disorders
English (EN) (178.12 KB - PDF)
Overview of comments received on the draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders
English (EN) (207.17 KB - PDF)
Draft guideline on clinical investigation of medicinal products in the treatment of lipid disorders - Revision 1 and 2
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.
English (EN) (173.37 KB - PDF)
Draft guideline on lipid lowering agents - Revision 1
This addendum replaces some chapters of the NfG on lipid lowering agents (CPMP/EWP/3020/03).
English (EN) (148.28 KB - PDF)
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
English (EN) (40.44 KB - PDF)
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
English (EN) (56.45 KB - PDF)
Document history - First version
Note for guidance on clinical investigation of medical products in the treatment of lipid disorders
English (EN) (180.16 KB - PDF)
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
English (EN) (27.17 KB - PDF)
Related content
- Clinical efficacy and safety: cardiovascular system
- Directive 2001/83/EC
- Choice of the non-inferiority margin
- Clinical investigation on medicinal products in the treatment of hypertension
- Clinical investigation of medicinal products in the treatment or prevention of diabetes mellitus
- Evaluation of medicinal products for cardiovascular disease prevention
- ICH E1 Extent of population exposure to assess clinical safety
- ICH E3 Structure and content of clinical study reports
- ICH E4 Dose-response information to support drug registration
- ICH E5 (R1) Ethnic factors in acceptability of foreign clinical data
- ICH E6 (R1) Guideline for good clinical practice
- ICH E7 Studies in support of special populations: geriatrics
- ICH E8 General considerations for clinical trials
- ICH E9 Statistical principles for clinical trials
- ICH E10 Choice of control group in clinical trials
- ICH E11 Clinical investigation of medicinal products in the pediatric population
- Multiplicity issues in clinical trials
- Paediatric addendum to the guideline on clinical investigation of medicinal products in the treatment of lipid disorders
- Switching between superiority and non-inferiority