Second phase of compound danshen dripping pills by recognized Chinese medicine into the United States hospital one step

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8 early morning of the 8th, tasly group factory, “ modern internationalization of traditional Chinese medicine the opening ” opened inscriptions. Recently, the company’s production of proprietary Chinese medicine compound danshen dropping pill by the United States food and Drug Administration (hereinafter referred to as FDA), phase II clinical trial, and begin the phase ⅲ clinical study. Deputy Minister of health, Director of the State administration of traditional Chinese medicine Guoqiang Wang indicated, this means that the safety and efficacy of the proprietary Chinese medicines in China and quality control standards for the first time in the world’s most stringent drug agency FDA approval.

the breakthrough success of background is: so far only to raw materials of Chinese medicine, health products, foods, extracts and other non-identity of the drug exports, never “ upright ” out of the country. Going out of traditional Chinese medicine, why so hard?

traditional Chinese medicine for many years into the European and American

a is drug-free

at a recent “ international research alliances started and the modern traditional Chinese medicine compound danshen dropping pill United States FDA phase ⅱ clinical trial results report ” last, emergence of the national population and family planning Commission Deputy Director Zhao Baige made many people by surprise.

14 years ago, she as officials of the Ministry of science and technology, with many Chinese medicine enterprises began more than 10 applications for United States FDA clinical trials. However, the road twists and turns. Internationalization strategy of Chinese medicine began in &ldquo, 95 ” period. Was put forward to achieve the 2—3 official proprietary Chinese medicine into the Western mainstream medicine market objectives. However, “ 15 ” later, and &ldquo, 25 ” draws to a close, never go out of traditional Chinese medicine. When heard of compound danshen dripping pills by United States FDA phase ⅱ clinical trial, Zhao pigeon said, be sure to speak to express her excited mood.

reporter learned from the State administration of traditional Chinese medicine, Chinese medicine has spread to more than 160 countries and regions in the world, currently engaged in traditional Chinese medicine in the world of medical service personnel has reached more than 300,000 people, Chinese medicine exports reached US $ 1.46 billion. So far, there is no Chinese medicinal products in Europe and the United States drug register, cannot go on sales in pharmacies and hospitals.

for Chinese traditional medicine enterprises, “ drug ” this officially into European and American markets, has been the target of many Chinese medicine enterprise in China. But most of them were lost in the journey.

for example, the first to enter United States stock market —&mdash of Chinese pharmaceutical enterprises; Guizhou Tongji Hall, who has been has high hopes of Chinese people, but in April 2008, overseas stock markets only a year after, Tongji Church “ delisting ” try, FDA clinical validation thing, to no avail. In 2001, the United States FDA approved anticancer medicine Kanglaite injection in the United States access to clinical trials, successfully pass a period, however, when the project is officially launched the second phase clinical trials, but ran aground due to funding issues.

now, compound danshen dripping pill individual independence, went furthest. Introduction of tasly Group Chairman yanxijun said, after 3 years of compound danshen dripping pills in phase II trials in the United States 15 clinical trials Centre, the world’s most rigorous clinical studies proving its safety and effectiveness.

standard, financial and market

closed closed are the lion in

<p&gt Chinese medicine into the mainstream of Western medicine market, through the United States FDA approval is one of the main channel. Then approval why so hard?

United States FDA requirements, the candidate drug through phase III clinical trials may be licensed. Phase I clinical trial lasted about a year, mainly focus on the security of candidate drugs. Phase II clinical trials lasted an average of 2-3 years, mainly working on candidate drugs on the validity of the target disease. Phase III clinical trials General 2-4 years, test content is enrolling volunteers all over the world, approved the results of early trials, so that researchers can build a large database of information about the candidate drug safety and effectiveness.

“ is the most difficult, most of traditional Chinese medicine compound, particularly large number of active ingredients, it is difficult to explain clearly what is like a Western medicine which chemical substances at work. But FDA validation requirements you have to make it clear. &Amp;rdquo; Vice President of tasly group Sun He said.

President of Tianjin University of traditional Chinese medicine, Chinese Academy of engineering academician Zhang Boli said “ sort out the difficulties encountered in the process of internationalization of traditional Chinese medicine, a very big problem that is on the development of traditional Chinese medicine production standards and international gap. We are not too familiar with foreign standards on the one hand, on the other hand we want to improve their technical standard. &Amp;rdquo;

Fang Shuting said, Chairman of China Association of traditional Chinese medicine, Chinese medicine go to “ three passes ”. First passes is “ standard closing ”。 High threshold of technical barrier and the Green trade barrier to Chinese medicine products to access international markets set a huge barrier. Second Commissioner of customs and customs is funding. Drugs declared FDA must review, demonstration, the longest time consuming 8—12 years, often spending up to 300 million —5 of millions of dollars. Commissioner of customs and the third is the market close. Herbs for the month a go, if you do not have access to market recognition, lack of sales network support is still not open.

statistics show that only about one-fifteenth of all candidate drug through the FDA phase III clinical trials and eventually meet with consumers. Such a high mortality rate, coupled with the high cost of clinical trials and long time, some Chinese medicine enterprises only in domestic “ swimming ”, and not “ &rdquo took ship at sea; into the international market.

served as United States FDA measurement of clinical pharmacology and highest level of review officers, Chief Scientist of Sun He said “ when the enterprise in the international market, first of all to the drug laws in various countries for a comprehensive understanding of the only fully understood on the basis of these regulations, procedures, research to meet the requirement, are in order. &Amp;rdquo;

must internationalization of traditional Chinese medicine

otherwise, loss of voice

in today’s nature, natural medicines, such as market development prospect of traditional Chinese medicine, and has become an attractive piece of cheese. In recent years, some international multinational pharmaceutical companies have invested in China to establish the appropriate research and development institutions.

room book stall at the view, at present, these companies with natural plant medicine research and development of ideas, not involved in research and development of Chinese medicine compound, which has a direct relationship between degree of legal recognition for traditional Chinese medicine in Europe and America. Once a breakthrough but laws and regulations, by virtue of its strong economic strength and technological power of transnational corporations, domestic Chinese medicine research and development institutions and enterprises will be have to “ door ” to meet that challenge.

This concern in the Chinese medicine practitioners have long resonate. Yanxijun believes that Chinese enterprises do not go out of traditional Chinese medicine, not to meet the challenge of internationalization, not only the loss of technology, market, even lose right to participation in the Accreditation regulations, industry standards, say. &Amp;ldquo; is an irreversible trend of internationalization of traditional Chinese medicine. &Amp;rdquo;

therefore, in recent years, by the voice of the Chinese medicine, to develop international standards going action also stops for a moment. In 2009, the International Organization for Standardization Technical Committee on Chinese medicine in Shanghai. Vice Chairman of the World Federation of Chinese medicine said Huang Jianyin, “ in the system developed under the International Organization for Standardization international standard, implemented in favour of traditional Chinese medicine in international markets. &Amp;rdquo;

over the years, many experts believe that currently faces new opportunities for international environment and development of traditional Chinese medicine.

Sun He believes that United States FDA on plant doors have been opened, and as open as possible, ideas more and new, some ideas change is difficult to imagine.

in order to seize new strategic opportunities, internationalization of traditional Chinese medicine in China began “ lock out ”. A few days ago, a Union in the world of traditional Chinese medicine has started, guiding the Alliance by national authorities, tasly Group lead, the first batch of members including Peking University, Beijing University of Chinese medicine, over more than 10 units, designed to integrate elements of research and development, technology, talent, capital and other resources, Heli restricting the breakthrough in the process of internationalization of bottlenecks.

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