Launch of public consultation to start discussion on clinical studies of herbal medicines in children

19 January 2011

The Agency's Committee on Herbal Medicinal Products (HMPC) has launched a public consultation to initiate discussion on the conduct of clinical studies with herbal medicinal products in children. The call is open until 15 April 2011.

Herbal medicines are widely used throughout the European Union, often in children. Despite this, little clinical information is available to allow the evaluation of their indications, dose, length of treatment and safety when used in children.

The initiative described in the Draft reflection paper on the necessity of initiatives to stimulate the conduct of clinical studies with herbal medicinal products in the paediatric population published today aims to focus on the following approaches:

• identification of herbal substances and preparations expected to have a therapeutic benefit, selected on the basis of criteria identified by the HMPC and the Paediatric Committee (PDCO);
• guidelines and recommendations for developing paediatric studies for herbal medicines;
• promotion of funding to collect more data on monitoring the safe use of these medicines in children and to promote further research.

The overall aim of the initiative is to stimulate research through the development of clinical studies on herbal medicinal products developed for children.

Comments and related data should be sent to [e-mail] using the template provided.