I-Hsin LINChairperson, Committee on Chinese Medicine and Pharmacy, Dept. of Health/Taiwan

According to the labor division of departments and commissions for the Chinese Medicinal Herbal Development Program 2001-2005, Executive Yuan, the Department of Health takes charge of the environment of clinical trial for traditional Chinese medicine and regulations in Taiwan. For a sound clinical trial environment for new Chinese medicines, the Department of Health announced the Guidelines for the Examination and Registration of New Chinese Medicines on June 29, 1998 and announced its amendments on October 20, 1999 as the compliances for clinical trials of new Chinese medicines. Moreover, 15 teaching hospitals have been subsidized for the establishment of clinical trial centers for traditional Chinese medicine as places for clinical trials of new Chinese medicines. From 2001 till now, the Committee on Chinese Medicine and Pharmaceuticals (CCMP), Department of Health has received 22 projects of new domestically developed Chinese medicines by IND; amidst, there are 14 with the approval of execution and 4 with accomplished trials.

The mechanism establishment of a clinical trial environment for traditional Chinese medicine and regulations, the domestic R&D of new Chinese medicines has demonstrated excellent achievements. The first new Chinese medicine certified by investigational new drug (IND) and new drug application (NDA) in terms of the regulations prescribed in the Guidelines of the Examination and Registration of New Chinese Medicines has entered the market. The main ingredient is Monascus- fermented rice. The domestic pharmaceutical manufacturer has been commissioned to make Monascus capsules by the domestic pharmaceutical merchant. The clinical trial application of the preceding drug was approved by the Department of Health for the assessment of clinical trial therapeutic effects conducted by a teaching hospital for over a year. After the clinical trial was finished, the experts were invited by the Department of Health to conduct good clinical practice (GCP) in the hospital in charge of the execution of trial for inspection. The new drug conforms to the regulations after all of the preceding procedures. The new drug’s application for the examination and registration of new Chinese medicine was submitted to the Drugs Examination Commission, Department of Health, Executive Yuan, for examination and resolution; the license was issued with the indication of “reduces high cholesterol and high triglyceride of blood” and effective for “digesting food, activating blood and increasing the overall health of the spleen and stomach”. The project is the first new Chinese drug certified by IND and NDA. In addition to expressing the competence of the national biotech industry concerning R&D of new Chinese medicines, it indicates that the national examination quality for Chinese medicines conforms to the modernization and scientific methods, which encourages national manufacturers to develop products in accordance with international routines and enter international markets to create a new era for Chinese medicinal herbs.

In addition, CCMP has been commissioning 93 projects to universities and the affiliated hospitals for clinical trials. The clinical trial centers for traditional Chinese medicine, subsidized and supported by CCMP, have conducted 105 projects concerning clinical trial research (including the reassessment of Chinese drugs in the market), of which most are supported by the budget of CCMP and some are commissioned by manufacturers and research centers.