Scientific evaluation of herbal medicinal products by the HMPC.

On 31 May/1 June and on 21/22 July 2005, the Committee on Herbal Medicinal Products (HMPC), which was founded in September 2004, met for the 5th and the 6th time, respectively, at the offices of the European Agency for the Evaluation of Medicinal Products (EMEA). A number of guidance documents has been elaborated by the Committee’s drafting groups on organisational matters, on quality and on safety and efficacy. As far as finalised by the Committee, these documents have been made available on the EMEA website for public consultation (www.emea.eu.int). The revised Guideline on quality of herbal medicinal products/traditional herbal medicinal products (CPMP/ QWP/2819/00 Rev 1) updates an existing Note for Guidance on quality of herbal medicinal products, now including traditional herbal medicinal products as well. According to the draft, all general principles of quality also apply to traditional herbal medicinal products. Regarding e.g. stability testing, the recommendations given in the existing guideline have not been changed. Another revised draft, the Guideline on specifications: Test procedures and acceptance criteria for herbal substances, herbal preparations and herbal medicinal products/traditional herbal medicinal products (CPMP/ QWP/2820/00 Rev 1), also updates an existing Note for Guidance by introducing new definitions and clarifications as well as by including traditional herbal medicinal products according to Directive 2004/24/EC. As the scope of this Directive also covers herbal products, which may additionally contain vitamins or minerals, specific aspects linked to such mixtures are described. Regarding quality standards and consumer safety, a further Draft public statement on Good Agricultural and Collection Practice for starting materials of herbal origin (EMEA/HMPC/246816/2005) has been published which is based on the existing Points to Consider on Good Agricultural and Collection Practice. It is intended to be used as a basis for the establishment of an appropriate quality assurance system and addresses specific concerns of growing, collecting and primary processing of medicinal plant material. In order to enable consistent preparation of two different types of monographs within the Committee