Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population - Scientific guideline

This document highlights the lack of clinical studies on the majority of herbal medicinal products (HMPs) in children. It reflects the need for initiatives to stimulate the conduct of clinical studies with HMPs properly designed for children.

Keywords: Herbal medicinal products, clinical studies, paediatric population

Current version

Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

Adopted Reference Number: EMA/HMPC/833398/2009 Legal effective date: 13/09/2011 Summary:

The aim of this document is to highlight the lack of clinical studies on the majority of herbal medicinal products in children and the need for initiatives to stimulate the conduct of clinical studies with HMPs properly designed for children.

Document history - First version (current)

Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

Adopted Reference Number: EMA/HMPC/833398/2009 Legal effective date: 13/09/2011 Summary:

The aim of this document is to highlight the lack of clinical studies on the majority of herbal medicinal products in children and the need for initiatives to stimulate the conduct of clinical studies with HMPs properly designed for children.

Overview of comments received on 'Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population’

Reference Number: EMA/HMPC/354690/2011

Draft reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population

Draft: consultation closed Consultation dates: 18/01/2011 to 15/04/2011 Reference Number: EMA/HMPC/833398/2009