Necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population - Scientific guideline
Table of contents
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
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Reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population (PDF/101 KB)
Adopted
First published: 28/02/2012
Last updated: 28/02/2012
Legal effective date: 13/09/2011
EMA/HMPC/833398/2009 -
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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’ (PDF/230.51 KB)
First published: 28/02/2012
Last updated: 28/02/2012
EMA/HMPC/354690/2011 -
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Draft reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population (PDF/129.23 KB)
Draft: consultation closed
First published: 19/01/2011
Last updated: 19/01/2011
Consultation dates: 18/01/2011 to 15/04/2011
EMA/HMPC/833398/2009