Herbal medicines in China are normally considered as medicinal products with special requirements for marketing that include quality dossiers, safety and efficacy evaluation, special labelling etc. The Drug Administration Law of the People’s Republic of China enacted in 1984 encourages the state to develop both modern and traditional drugs and the state protects the resources of wild herbal drugs and encourages domestic cultivation of herbal drugs. While traditional experiences with regard to therapeutic efficacy are held in esteem, modern scientific and technical knowledge is used in appraising the therapeutic effects and quality of modified traditional medicines, thus contributing administratively to the exploitation of TCM. According to article 5 of the Drug Administration Law of China an herbal drug manufacturing enterprise should be staffed with an adequate number of technical personnel and skilled workers capable of handling large-scale drug production. Units engaged in handling plant material need to be staffed with pharmaceutical professionals familiar with the property of raw materials and registered with the health bureau above the county level. Article 6 requires medicinal plant material processing to be carried out in compliance with the pharmacopoeia of the People’s Republic of China or the processing norms stipulated by the health bureau of the province, autonomous region or municipality. The Drug Administration Law also stipulates the places of disbursement and sale of medicinal pant materials and has under its purview norms for the export, import, patenting and clinical trial requirements of such products.

Even new drugs are examined and approved according to the Drug Administration Law. Upon approval, a New Drug Certificate is granted an approval number and the factory is permitted to put the product on the market. ‘New Drugs’ are referred to as drugs which have not been produced previously in China, or drugs for which a new indication, a change in the route of administration or a change of dosage form is to be adopted.

Traditional Chinese medicines are often composed of multiple herbs, which have been selected by a TCM practitioner to treat specific diseases in individual patients. Since these are ‘individualized’ converting a TCM into a pharmaceutical product is challenging as the latter requires a specific composition. Defining a specific composition can be tricky because the efficacy of a TCM preparation may be used over a range of compositions. Overall, developing TCM as pharmaceutical drugs presents unique challenges, including coping with multiple herbs, controlling the cultivation of the biomass and steps for processing it adhering to GMP. Applicants engaged in the development, production, distribution, prescription, inspection and surveillance of new drugs must adhere to the provisions of articles 21 and 22. The regulation includes general principles concerning new drugs, their classification, research, clinical trials, approval and manufacture. Appendices to the document provide detailed information on the application form, list of documents required and technical requirements of toxicological and clinical studies on new modern drugs and new TCM drugs.