Committee on Herbal Medicinal Products

The revised legislation (Regulation 726/2004) established a new committee within the structure of the EMEA named the Committee on Herbal Medicinal Products (HCMP). This committee has the task to provide the MS and the institutions of the Community with the best possible scientific advice on any question relating to the evaluation of the quality, safety and efficacy of medicinal products , as well as advising interested parties on the conduct of the various tests and trials necessary to demonstrate quality, safety and efficacy. 

EMEA. 2008. Community herbal monograph on Solidago virgaurea L., heiba. London European Medicines Agency, Committee on Herbal Medicinal Products. 

EMEA. 2005. Final position paper on the use of herbal medicinal products containing estragole. European Agency for the Evaluation of Medicinal Products, Committee on Herbal Medicinal Products. EMEA/HMPC/137212/2005. 

All other homeopathic and herbal medicines that do not qualify for simplified registration procedures will have to go through the standard authorisation procedure with supporting technical dossiers. The Committee for Herbal Medicinal Products has been charged with preparing monographs on herbal products so as to further facilitate the registration of traditional and well-established use herbal products. 

Starting as an Ad Hoc Working Group on Herbal Medicinal Products in May 1997, there evolved a Herbal Medicinal Products Working Party (HMPWP) which had been operational as regards traditional herbal medicinal products imtil August 2004. However, Article 16h of Directive 2004/24/EC of 31 March 2004 formally established the Committee for Herbal Medicinal Products (HMPC). 

Advisory Committee (HMAC). This Committee would advise Ministers directly on areas for which the Committee is responsible. The remit of HMAC would be the registration scheme to be introduced under the Directive 2004/24/EC on Traditional Herbal Medicinal Products and unlicensed herbal medicines. However, CHM will be responsible for advice in relation to marketing authorizations for herbal medicines. Professor Philip Routledge has been appointed the first Chairman of HMAC, for a term of 4 years effective from 30 October 2005. 

Good Manufacturing Practices supplementary guidelines for the manufacture of herbal medicinal products. In WHO Expert Committee on Specifica-... 

The Office of Alternative Medicines (0AM) was also established at this time for the study and compilation of data on alternative medicines. The 0AM functions within the NIH, and it is hoped that the 0AM can further clarify the role of alternative medicines such as herbal remedies in this country. In other countries, similar committees (such as Commission E in Germany) have reviewed the safety and efficacy of herbs and published the results so that product debates can be resolved. 

A provisional tolerable weekly intake, PTWI, of lead was determined (by a Joint Food and Agriculture Organization/World Health Organization Expert Committee on Food Additives, JECFA) to be 0.025 mg/kg body weight in 2004 [11]. Also in 2004, the WHO s standard for lead in drinking water was 0.01 mg/L [11]. In addition as mentirmed in a 2007 WHO pubhcation, the WHO recommendation for the limit of lead in herbal medicines and products was 10 mg/kg [12]. 

In 2004 the Joint Food and Agriculture OrganizationAVorld Health Organization Expert Committee on Food Additives (JECFA) recommended the provisional tolerable weekly intake of cadmium as 0.007 mg/kg body weight [15]. Also the WHO (in 2004) adopted the provisional guideline of 0.003 mg/L for cadmium in drinking water [15]. In addition, a 2007 WHO publication recommended the limit of cadmium in herbal medicines and products to be 0.3 mg/kg [16]. 

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