Jedi break through into the mainstream of international market of internationalization of traditional Chinese medicine has a long way
Tianjin, Xinhua, August 8 (reporter Liu gang, Meng Hua, and Qian Wang) treasure is the heritage of the Chinese nation 5,000 years of Chinese medicine, Chinese medicine industry is China’s traditional industries. However, frustrations is the process of internationalization of traditional Chinese medicine in China all the way. More embarrassing is that so far no cases of proprietary Chinese medicines in China drug identity are exported to European and American mainstream medicine market, break through the internationalization of traditional Chinese medicine urgently looking forward to the Jedi.
tasly <span ID="quote_sh600535">, (32.60 , -0.47,<font color="#008000">-1.42%) </span> company products of traditional Chinese medicine compound danshen dripping pills in July this year to become China's first successful through the United States food and Drug Administration (FDA), phase ⅱ clinical trial confirm their safe, effective, and enters the FDA phase ⅲ clinical trial of proprietary Chinese medicines, marked the internationalization of traditional Chinese medicine has made a major breakthrough. However, the process of traditional Chinese medicine to the world as a whole is still a long, long road to go.
breakthrough Jedi —— internationalization of traditional Chinese medicine breakthrough
<p> due East-West drug objective differences, laws, culture, knowledge, and multiple reasons such as components of Chinese drugs complex, Western countries generally sceptical as drugs of traditional Chinese medicine to declare. China is a Chinese traditional medicine production power, but currently no cases of proprietary Chinese medicines in China drug identity are exported to European and American mainstream medicine market, Chinese medicine exports less than international market of Chinese herbal medicine one-tenth.
<p> Chinese medicine into the mainstream of Western medicine market, through the United States food and Drug Administration (FDA) approval is one of the main channel. However, FDA clinical trials is a big investment, long period, high risk and complex projects. Typically, a new drug from the basics to get FDA grant clinical official written reply to phase III clinical trials take 10 years to the end of 13 hours, research and development spending up to $ 500 million to 600 million, some Chinese medicines in the United States FDA clinical trials attempt ended in failure early. Internationalization of traditional Chinese medicine so tortuous, expensive, became so many that internationalization of traditional Chinese medicine enterprises dared not touch the nerves.
&ldquo through FDA United States markets permit, is the challenge of internationalization of traditional Chinese medicine must pass, speeding up the process of internationalization of traditional Chinese medicine cannot bypass these obstacles, must face the challenge. &Amp;rdquo; former United States FDA measures, Chief Scientist and the highest level of clinical pharmacology review one of the official introduction of tasly Group Vice President of Sun He.
the United States is the world’s largest drug market. Because it is not through the FDA approval to market, Chinese medicines of traditional Chinese medicine can only be sold in the form of health care, low cost, minimal market, lost to enter United States mainstream drug market opportunities. At the same time, due to the authority of the FDA in the pharmaceutical industry in the world, through the FDA approval to market its products more convenient access to Europe, Latin America and Southeast Asia market played a significant role in promoting.
tasly compound danshen dripping pill once in 1997 and the first United States before the FDA clinical applications, after experiencing twists and turns in the last decade to explore, get FDA clinical official written reply once again in 2006, after experienced a lot of basic research and clinical trials, becoming China’s first successful through United States FDA phase ⅱ clinical trials shall be conclusive evidence of its safe and effective traditional Chinese medicine.
“ compound danshen dripping pill became the first successful United States FDA phase II clinical study of compound preparation of traditional Chinese medicine, this is an important landmark in the development of traditional Chinese medicine in China big things, it shows like Chinese medicine and Western medicine, to withstand the Western Europe and national standards of safety and efficacy of stringent tests to promoting more outstanding proprietary Chinese medicines in China into the international market has a positive role model. &Amp;rdquo;, Vice Minister of health Wang Guoqiang said.
hard road is more urgent breakthrough of bottleneck restricting the internationalization of traditional Chinese medicine
This is the implementation of the 2002-2010 the modernization of traditional Chinese medicine key to the development of the platform for a year, the platform proposed “ fight for varieties of traditional Chinese medicine into the mainstream of international pharmaceutical market &rdquo 2-3;. However, the present situation of development, at about 2000 years before applying for FDA clinical applications in very few enterprises, apart from outside the compound danshen dripping pill has completed clinical phase II, most organizations discourage or reactive power back.
“ sort out the difficulties encountered in the process of internationalization of traditional Chinese medicine, a very big problemIs the development of Chinese medicine production standards with the international gap. &Amp;rdquo; President of Chinese Academy of engineering, Tianjin University of traditional Chinese medicine said Zhang Boli.
due to differences in cultural background and theoretical system, the scientific connotation of Chinese medicine has not yet been widely understood and accepted by the international community, international law has not been established in accordance with traditional Chinese medicine on the development of international standards, lack of technical standards of Chinese medicine services, product face chemical or food standards, such as technical barriers to policy restrictions.
“ we really want to understand the West’s technical standards on the one hand, this threshold was in existence, is not really designed for setting of traditional Chinese medicine, so they need to learn communication; on the other hand, from the medicine we source, extraction, production, quality control and so enhance their research and development of technical standards. &Amp;rdquo; Zhang Boli said.
also, Guoqiang Wang pointed out that, at present, foreign exchange and cooperation of Chinese medicine has not yet been formed with the guidance of national development strategies; Chinese medicine exports bulls management, poor quality parameters do not align, ancient prescription of traditional Chinese medicine such as lack of effective means of protection of traditional knowledge, lack of effective international emergency response and resolution mechanism, these issues are to a certain extent restricted the development of Chinese medicine and international spread.
and export-oriented management talents and serious lack of expert staff is also hindering important aspects of the internationalization of traditional Chinese medicine. &Amp;ldquo; go past some of our enterprise success is not even the international standards system of the text are not read. &Amp;rdquo; Zhang Boli believes that “ therefore, we must have international global consciousness, with open minds make great efforts to introduce expert familiar with the overseas registration of drug research and development, and train a number of international talents of Chinese medicine, and build bridges between East and West &rdquo.
the success of holding out? Chinese Materia Medica internationalization remain formidable
with the transformation of human health and the medical model, advantages and features of traditional Chinese medicine in prevention and treatment of modern diseases are being recognized and accepted by the growing number of countries and regions. &Amp;ldquo; more countries and regions concerned the development of Chinese medicine, pinning their hopes on Chinese medicine to medical and health services in countries play a greater role in the system, and to seek more exchanges and cooperation in traditional Chinese medicine. &Amp;rdquo; Guoqiang Wang describes Vice Minister.
in recent years, who continue to develop and publish for the development of traditional medicine strategy, policy and standards, promotion on a global basis includes the development of traditional medicine, traditional Chinese medicine. While the United States began to recognize the scientific system of traditional Chinese medicine as a separate. Chinese medicine is under unprecedented concern to the international community, faced with rare opportunities for development.
“ however, in the process of internationalization of traditional Chinese medicine, due to the drug, technologies, standards, research, funding, personnel and other aspects of many challenges, with only a few enterprises, a few varieties, stragglers and disbanded soldiers battle mode, in the current medicine and increasing competition, new technology, new standards under the background of emerging, it is difficult to achieve the overall historical mission of the internationalization of traditional Chinese medicine industry. &Amp;rdquo; tasly Group President yanxijun said.
in order to seize new strategic opportunities, internationalization of traditional Chinese medicine in China began “ lock out ”. As a major national science and technology of special support projects, 17 by tasly and Peking University College-enterprise joint “ modern internationalization of traditional Chinese medicine research ”7 day of the League was officially launched. Designed to integrate all aspects of production, teaching and research resources of research and development, technology, talent, capital and other factors, to restricting the breakthrough in the process of internationalization of bottlenecks. Transformation of compound danshen dripping pills FDA clinical trial achievements award as shared resources, serve more enterprises.
“ this is promoting modernization of traditional Chinese medicine approach of important strategic initiatives, marked in the new historical conditions in China under the Chinese medicine industry enters a new stage of development, to enhance independent innovation and enhance international competitiveness of Chinese medicine in China, promote greater development in the international scope of significance. &Amp;rdquo; Guoqiang Wang said.
Assistant President of Jilin xiuzheng pharmaceutical group Zhao Quancheng pointed out that “ lock out ” established technology and product innovation as core, with benefit-sharing as a link, to the contractual relationship for the protection of technology innovation Alliance, “ herbs for the month will be more domestic enterprises to open up the shortcut to a specialization, standardization. &Amp;rdquo;
however, the world is still a long process of traditional Chinese medicine, a long way to go. &Amp;ldquo Chinese medicine to the world of road to gradual and orderly progress. &Amp;rdquo; Guoqiang Wang said, “ for example, to ‘ first drug Hou medical ’, to let world first see good of products, to promote more of people understanding TCM of diagnosis method; ‘ first within Hou outside ’, enterprise to first do strength, in domestic practice in the improve effect and specification standard is to world of Foundation; ‘ first points behind ’, in global select international cooperation of combination points, innovationWays methods of international cooperation, the adoption of the model-driven better overall to the world of traditional Chinese medicine. ”