Committee for Herbal Medicinal

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. 

In view of the increasing profile and use of herbal medicines, the European union has established a Committee for Herbal Medicinal Products (see chapter 17). The MHRA consulted and has also established a Herbal Medicines... 

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). 

The Committee for Herbal Medicinal Products (HCMP) has been given the task of preparing a list of herbal substances, herbal preparations and combinations thereof to be used in traditional herbal medicinal products. The list will contain for each substance the indication, strength, posology, route... 

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. 

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. 

The medical use of botanicals in their natural and unprocessed form undoubtedly began when the first intelligent animals noticed that certain food plants altered particular body functions. Much information exists about the historical use and effectiveness of botanical products. Unfortunately, the quality of this information is extremely variable. One of the most complete compendiums of clinical recommendations regarding the use of botanicals is the Report of the German Commission E (a committee that sets standards for herbal medications in that country Blumenthal, 2000). Interest in the endocrine effects and possible nutritional benefits of certain purified chemicals such as dehydroepiandrosterone. melatonin, high-dose vitamins, and minerals has led to a parallel development of consumer demand for such substances. These substances, together with the botanicals, constitute a substantial source of profits for those who exploit the concept of "alternative medicine."... 

Official standards are absolutely necessary to ensure the quality, reliability, and homogeneity of herbal products for consumers. Standardized products are paramount to those in healthcare planning to conduct clinical research with these products. Independent laboratories and university-affiliated research reports have documented the considerable variation that exists in terms of quality and reliability in these products. Abroad, the ESCOP, composed of manufacturers of herbal medicines and herbal associations, is working with European research groups to develop quality-control standards for the production of natural products. This committee is developing monographs for incorporation into such references as the British Herbal Pharmacopoeia and the British Herbal Compendium. 

In a 5-year toxicological study of traditional remedies and food supplements carried out by the Medical Toxicology Unit at Guy s and St. Thomas Hospital, London, 1297 symptomatic enquiries by medical professionals were evaluated (28). Of these, an association was considered to have been confirmed, probable, or possible in 12, 35, and 738 cases respectively. Ten of the confirmed cases were related to Chinese or Indian herbal remedies. As a result of these findings, in October 1996 the UK Committee on Safety of Medicines extended its yellow card scheme for adverse drug reaction reporting to include unhcensed herbal remedies, which are marketed mostly as food supplements in the UK (the scheme had always apphed to hcensed herbal medicines) (29,30). This was an important milestone in herbal pharmacovigilance. 

The Committee expressed the need for capacity building in countries to facilitate improved quality assurance and quality control of herbal medicines. 

The Committee was informed that the supplementary guidelines on GMP for the manufacture of herbal medicines had been reviewed and updated over recent years through an extensive consultation process. The Committee adopted the document with minor editorial corrections (Annex 3). 

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

Guidelines for the assessment of herbal medicines. In WHO Expert Committee on Specifications for Pharmaceutical Preparations. Thirty-fourth report. Geneva, World Health Organization, 1996 (WHO Technical Report Series,... 

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]. 

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. 

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