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

This document is an addendum to the guideline on the clinical investigation of medicinal products used in weight control for adults. It provides guidance on the clinical investigation of medicinal products used in weight control in the paediatric population.

Keywords: Obesity, weight control

Current effective version

Guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children

Adopted Reference Number: EMEA/CHMP/EWP/517497/2007 Legal effective date: 01/02/2009

Document history - revision 1

Concept paper on the need for revision of the addendum on weight control in children to the guideline on clinical evaluation of medicinal products used in weight control

Draft: consultation closed Consultation dates: 02/12/2024 to 28/02/2025 Reference Number: EMA/501950/2024 Summary:

The proposed guideline will replace Guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children (EMEA/CHMP/EWP/517497/2007).

Comments should be provided using this EUSurvey form. For any technical issues, please contact the EUSurvey Support.

Document history - First version (current)

Guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children

Adopted Reference Number: EMEA/CHMP/EWP/517497/2007 Legal effective date: 01/02/2009

Overview of comments received on draft guideline on clinical evaluation of medicinal products used in weight control - weight control in children

Reference Number: EMEA/402888/2008

Draft guideline on clinical evaluation of medicinal products used in weight control - Addendum on weight control in children

Draft: consultation closed Reference Number: EMEA/CHMP/EWP/517497/2007