Clinical evaluation of medicinal products used in weight control - Scientific guideline

This guideline provides medicine developers guidance on the clinical evaluation of new medicinal products for promoting weight loss in obese adult patients.

This guideline provides medicine developers guidance on the clinical evaluation of new medicinal products for promoting weight loss in obese adult patients. It clarifies the requirements for the clinical documentation needed to support a marketing authorisation of weight management medicines, including the recommended methods for assessing efficacy, selection of patients, strategy and design of clinical trials.

For guidance on clinical investigation of treatment of obesity in children, see the addendum to this guideline.

Keywords: Obesity, weight control

Current version

Guideline on clinical evaluation of medicinal products used in weight management

Adopted Reference Number: EMA/CHMP/311805/2014 Legal effective date: 01/01/2017

Overview of comments received on Guideline on clinical evaluation of medicinal products used in weight control - Revision 1

Reference Number: EMA/414592/2016

Draft guideline on clinical evaluation of medicinal products used in weight control - Revision 1

Draft: consultation closed Consultation dates: 31/07/2014 to 31/01/2015 Reference Number: EMA/CHMP/311805/2014 Summary:

This guideline represents the second revision of the CPMP Guideline on clinical investigation of medicinal products used in Weight Control (CPMP/EWP/281/96). It is intended to provide guidance for the clinical evaluation of new medicinal products used to promote weight loss in obese adult patients.

Concept paper on the need for revision of the guideline of medical products used in weight control - Revision 1

Draft: consultation closed Consultation dates: 01/10/2012 to 31/12/2012 Reference Number: EMA/CHMP/229823/2012 Summary:

The current guideline on medicinal products used in weight control (CPMP/EWP/281/96 Rev.1) was adopted by the Committee for Medicinal Products for Human Use on 15 November 2007. Since then, the marketing authorisations of two weight-control medicinal products have been suspended in the EU due to cardiovascular and neuropsychiatric side effects. Given the dramatic worldwide increase of obesity and overweight, in depth evaluation of overall benefit/risk is a crucial issue. Thus, revisions of the requirements both with respect to efficacy and safety are warranted.

Document history - first version

This version was in effect from 31 May 2008 to 31 December 2016.

Guideline on clinical investigation of medicinal products used in weight control

Adopted Reference Number: CPMP/EWP/281/96 Rev.1 Legal effective date: 31/05/2008

Draft guideline on clinical investigation of medicinal products used in weight control

Draft: consultation closed Reference Number: CPMP/EWP/281/96 Rev.1