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

AdoptedReference Number: EMEA/CHMP/EWP/517497/2007Legal 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 closedConsultation dates: 02/12/2024 to 28/02/2025Reference Number: EMA/501950/2024Summary:

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

AdoptedReference Number: EMEA/CHMP/EWP/517497/2007Legal 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 closedReference Number: EMEA/CHMP/EWP/517497/2007