China’s first proprietary Chinese medicines through United States FDA ⅱ clinical trial

the people’s network, Beijing, August 7 (reporter Chen Jie, Wang Junping) this morning, the modern traditional Chinese Medicine Association of international research in Beijing starts. From the national launch ceremony organised by the Ministry of health with the Tianjin Municipal Government was informed that, tasly group of compound danshen dripping pills become China’s first complete United States food and Drug Administration (FDA), phase II clinical trial, is about to enter phase III clinical trials of traditional Chinese medicine. After the Union put into operation, concentrated efforts, innovative proprietary Chinese medicines into mainstream international pharmaceutical market. Sang Guowei, Vice Chairman of the NPC announced the Union starts.

modern traditional Chinese medicine compound danshen dripping pills in 1997 to become China’s first cases were United States FDA clinical trials approval documents of the compound preparations of traditional Chinese medicine. Ten years after, Tianjin tasly group through a lot of basic research in the country, in 2007, FDA phase ⅱ clinical trial, clinical trials in the United States 15 clinical centers in different regions, in accordance with internationally accepted code for quality management in clinical trials of drugs (GCP) strictly, all research at the beginning of this year successfully concluded, results shall be conclusive evidence of compound danshen drop pills safe, effective, quality-controlled.

introduction of tasly Group Chairman yanxijun, will be established in the world in 2 years from 50 to 70 clinical trials Center, complete the FDA phase III trials, building an access road for internationalization of traditional Chinese medicine.

“ compound danshen dripping pills into the FDA phase III trials, mark key and a strong step in the internationalization of traditional Chinese medicine, traditional Chinese medicine in the clinical evaluation of comprehensive research and development production, achievements have been recognized by the international. &Amp;rdquo; the Chinese Academy of engineering academician Zhang Boli think.

“ modern Chinese Materia Medica internationalization Research Consortium ” tasly group is a leading implementation of the national &ldquo of significant new drug creation ” major special issues of science and technology, Union by tasly group and Beijing and Tianjin University, Beijing University of Chinese medicine, Tianjin University of traditional Chinese medicine 17 College-enterprise joint, organic combination of production, teaching and research, collaborative research. Union will FDA clinical trial of compound danshen dripping pills into resources, serve more of the enterprise, excellent variety of proprietary Chinese medicines in filtering domestic representative, in accordance with international standards for research and development of the system, sought to break through quality, safety and clinical evaluation of the key technical barriers, break the current impasse between the slow pace of internationalization of Chinese medicine

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