Regulatory Situation of Herbal Medicines A worldwide Review

WHO/TRM/98.1page 28product on the market. This procedure reflects the respect in which traditional experiences are held, whilemodern scientific and technical knowledge is used in appraising the therapeutic effects and the quality of themodified traditional medicines, and contributes administratively to the exploitation of traditional Chinesemedicine [128].The Drug Administration Law of the People's Republic of China [129] was enacted on 20 September 1984.Article 3 states "The State encourages the development of both modern and traditional drugs, the role of whichin the prevention and treatment of diseases as well as in health care will be fully brought into play. The Stateprotects the resources of wild herbal drugs and encourages domestic cultivation of herbal drugs".With regard to a drug manufacturing enterprise, Article 5 states that "It should be staffed with an adequatenumber of pharmacists or technical personnel with a title equivalent to or higher than associate engineer, andskilled workers adaptable to the scale of drug production". However, "Enterprises for the preparation andslicing of raw plant materials should be staffed with pharmaceutical professionals familiar with the property ofraw materials and registered with the health bureau above the county level, if pharmacists or technicalpersonnel with a title equivalent to or higher than associate engineer are not available." Article 6 states"processed medicinal plant materials must be prepared and sliced in compliance with the specifications ofthe Pharmacopoeia of the People's Republic of China or the processing norms stipulated by the health bureauof the province, autonomous region or municipality".For the control of drug handling enterprises, Article 11 states that a drug handling enterprise should beestablished with an adequate number of pharmaceutical technicians adaptable to the scale of its business.However, enterprises engaged in the handling of modern drugs may be staffed with pharmaceuticalprofessionals familiar with the property of drugs and registered with the health bureau above the county level, ifpharmaceutical technicians are not available. Article 15 states that in the market of country fairs only the sale ofmedicinal plant materials is permitted, with certain exceptions.Article 29 states "The Ministry of Public Health has the authority to restrict or prohibit the exportation ofmedicinal plant materials and patent herbal medicines if they are in short supply in the domestic market".Article 31 states "The sale of medicinal plant materials newly discovered or introduced from abroad is notallowed unless it is approved by the health bureau of the province, autonomous region or municipality" [129].Documentation for Applications for New DrugsBased on Article 21 of the Drug Administration Law, "the clinical trial or clinical verification of a new drug shouldbe sanctioned by the Ministry of Public Health or the health bureau of the province, autonomous region ormunicipality". "A new drug will be approved for clinical use and a licence issued by the Ministry of Public Health,if the clinical trial or clinical verification has been completed and an appraisal of its efficacy has been made."Pursuant to Articles 21 and 22 of the Drug Administration Law, on 1 July 1985, the Ministry of Public Healthissued and implemented a regulation for the Approval of New Drugs. "New drugs" are referred to as drugswhich have not been produced previously in China, or drugs for which a new indication, a change in the routeof administration or a change of dosage form is to be adopted. Any unit or individual engaged in thedevelopment, production, distribution, prescription, inspection and surveillance of new drugs must adhere tothe provisions of the document. The regulation includes general principles concerning new drugs, theirclassification, research, clinical trials, approval, and manufacture. Several appendices provide detailedinformation on the application form, list of documents required, and technical requirements of toxicological andclinical studies on new modern drugs, and new TCM drugs [127].Based on the Amendment and Supplemental Regulation of Approval of New TCM Drugs, implemented1 September 1992 [130], new TCM drugs are classified under five categories, as follows:Category 1- artificial imitations of TCM herbs;- newly discovered medicinal plants and their preparations;- single active principle extracted from TCM plants material and their preparations.Category 2- Chinese medicinal herbal injections;- parts of TCM medicinal plants newly employed as a remedy and their preparations;- non-single components extracted from TCM and natural plants and their preparations;- TCM materials obtained by artificial techniques in vivo and their preparations.Category 3- new TCM preparations;