The Committee on Herbal Medicinal Products (HMPC) is the European Medicines Agency's (EMA) committee responsible for compiling and assessing scientific data on herbal substances, preparations and combinations, to support the harmonisation of the European market.
The HMPC replaced the Committee for Proprietary Medicinal Products' Working Party on Herbal Medicinal Products in September 2004.
The Committee was established in accordance with Regulation (EC) No 726/2004 and the Herbal Directive, which introduced a simplified registration procedure for traditional herbal medicinal products in EU Member States.
The HMPC is composed of scientific experts in the field of herbal medicines.
Role of the HMPC
The HMPC prepares the Agency's opinions on herbal substances and preparations, along with information on recommended uses and safe conditions.
This work supports the harmonisation of the European market: national competent authorities are able to refer to one unique set of information on a herbal substance or preparation when evaluating marketing applications for herbal medicines.
To support EU Member States, the HMPC focuses on two main tasks:
- establishing EU monographs covering the therapeutic uses and safe conditions of well-established and/or traditional use for herbal substances and preparations;
- drafting an EU list of herbal substances, preparations and combinations thereof for use in traditional herbal medicinal products.
The HMPC and its working parties and other groups also:
- prepare scientific guidelines and regulatory guidance to help companies prepare marketing authorisation and registration applications for herbal medicines;
prepare opinions on questions referred to EMA by the national competent authorities regarding the period and evidence of safe use for traditional herbal medicinal products;
- cooperate with the European Directorate for the Quality of Medicines and Healthcare on European Pharmacopoeia standards and EMA guidance on the quality of herbal medicines;
- coordinate with other scientific committees at the Agency on the regulation and safe use of herbal medicines;
- provide scientific and regulatory support to companies researching and developing herbal medicines;
- interact with interested parties;
- provide advice and training to herbal assessors of national competent authorities;
- cooperate with international partners on the harmonisation of regulatory requirements.
For full details, see:
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European Medicines Agency
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