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| 2006011020060110the State Food and Drug Administrationepdf/e04723.pdfB3,A4traditional Chinese medicines prepared in ready-to-use forms, foreign investmente04723Circular of the State Food and Drug Administration on the Relevant Issues concerning the Business Scope of the Foreign-funded Enterprises Engaging in the Production of Herbal Medicines for DecoctionGuo Shi Yao Jian An [2006] No. 14The food and drug administration bureaus (drug administration bureaus) of all provinces, autonomous regions, and municipalities directly under the Central Government,According to the provisions of the Industrial Catalogue for Guiding Foreign Investment (promulgated by the Order No. 24 of the State Development and Reform Commission of the People's Republic of China and the Ministry of Commerce of the People's Republic of China) which came into force as of January 1, 2005, "the application of preparing techniques of traditional Chinese medicine in small pieces ready for decoction and the products of secret recipe of traditional Chinese medicine already prepared" falls within the category of industries prohibited from foreign investment.According to the General Rules on Processing Medicine Materials as prescribed in the Drug Code of the People's Republic of China (2005): "The term 'processing of medicine materials' refers to that medicine materials are manufactured into herbal medicines of certain specimen for decoction after cleaning, cutting, roasting and boiling so as to meet the requirements of medical treatment and mixture or preparation, and guarantee the safety and effectiveness of medication." The processing of medicine materials includes cleaning, cutting, roasting and boiling. The application of preparing techniques of herbal medicines for decoction refers to the application of the aforesaid processing techniques.In order to make the foreign investment compatible with the planning of the national economy and social development of China, the administrative departments of food and drug of all provinces (regions and cities) shall strictly implement the state policies and guard the access to the industries prohibited from foreign investment. As to any foreign-funded enterprise that has obtained the approval of access to prohibited industries, the administrative department of food and drug at the provincial level shall, when the relevant enterprise that engages in the production of herbal medicine for decoction renews its Pharmaceutical Production License, clearly indicate "cleaning and cutting" on the License so as to restrict the production scope thereof.State Food and Drug AdministrationJanuary 10, 2006 |
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