Establishement of Chinese Medicine Clinical Trials and Legislative Environment in Taiwan


I-Hsin Lin


Traditional & Complementary Medicine Exhibition 2007 (TCME 2007), Putra World Trade Centre (PWTC), Kuala Lumpur, Malaysia




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In 2002, an epoch-making report-“WHO Traditional Medicine Strategy” was announced, which suggested more than 180 countries worldwide the incorporation of WHO Traditional Medicine Strategy into their medical policy. The existence of traditional Chinese medicine has been over thousand years. It is a common medical resource for our citizens. Under well-planned and long-term promotions from our government, our systems of education, examination, application and R7D for traditional medicine are well constructed and became learning ideals for other countries. Therefore, delegates from 40 countries have visited Taiwan for this reason along. Except Taiwan and Mainland china, Chinese medicine is also popular in regions liked Asia, Europe, United States, Canada and Australia and gradually becomes a global trend. WHO evaluated that value of Chinese herb medicines in the world market attains to 60 billions US dollars. We should, therefore, keep track of this opportunity to create further development. Following the world trend, facing the global competitive and co-operative era. In order to create a favorable environment for development of Chinese medicine the executive Yuan of Taiwan had formulated the program “Strengthening of Biotech Industries” and set the science of Chinese medicine as a main developing task. In addition, our ministry of economic affair proposed a “5-year plan: technological development of TCM pharmaceutical industries”. According to this plan, CCMP draw up an outline for “Integrated Program of Chinese medical modernization and internationalization”, keep on training technical personnel and target to follow points 1) set up a control system against the quality if Chinese medicine 2) upgrade the standard of Chinese medicament 3) build up a mature environment for Chinese medicinal and clinical trials 4)advance on service quality of Chinese remedies 5) create an environment for development of Chinese medicinal Innovation and encourage clinical trials, promoter to find out new Chinese medicine and entry the international market as well. We have some important achievement in the past years, for example: (1) The Chinese medicine has been incorporated into the National Health Insurance. (2) Complete standards and regulations of Chinese medicine education, preclinical training, and certification are well established. (3) The overall practice of GMP in Chinese medicine had been reached by sep., 2005. (4) The “unified formula” of the Chinese medicine are announced and implemented. (5) 13 Clinical trial centers for traditional Chinese medicine are constructed. At the same time, a Chinese medicine hospital survey system has been established, GMP accreditation on traditional Chinese medicine manufactures has been carried out across the board and Taiwan’s first “Pharmacopoeia of Chinese Medicine” has been published, so as to assure the public’s safety in the aspect of medical treatment and medicine application and provide better Chinese medicine pharmacy service to them.