The internationalization of traditional Chinese medicine is breaking the situation and modernizing first

In the past 10 years, traditional Chinese medicine has made remarkable achievements in the process of internationalization The standard of Salvia miltiorrhiza developed by China pharmaceutical company has been included in the USP, and 5 varieties including Panax notoginseng have been included in the European Pharmacopoeia Recently, Xinxuekang produced by Chengdu Di'ao has also completed its registration in the EU In addition, the FDA registration of Chinese patent medicine has also made important progress The phase II clinical experiment of Fuzheng Huayu tablet developed by Shanghai Modern Chinese Medicine Co., Ltd has also been highly recognized by the US FDA after the US FDA registration of the compound Danshen dropping pill of Tianshili There is a new breakthrough for traditional Chinese medicine to enter the international market Recently, Fuzheng Huayu tablet successfully completed the phase II clinical trial in the United States, and is closer to the goal of entering the prescription drug market In the face of the situation that traditional Chinese medicine with unique advantages is hard to find a place in the world pharmaceutical market, more and more domestic traditional Chinese medicine enterprises begin to realize that traditional Chinese medicine must adapt to the "discourse system" of modern medicine to the world, and actively explore the "modern" internationalization of traditional Chinese medicine that is understood and accepted by all countries in the world, especially the westerners Recently, Fuzheng Huayu tablet, a Chinese patent medicine, has successfully completed phase II clinical trials in the United States, and has been highly recognized by the United States Food and Drug Administration (FDA) It is expected to become the first compound Chinese medicine approved to enter the mainstream pharmaceutical market in the United States, adding a lot to the modernization and internationalization of traditional Chinese medicine In the past 10 years, traditional Chinese medicine has made remarkable achievements in the process of internationalization The standard of Salvia miltiorrhiza developed by China pharmaceutical company was included in USP, and 5 varieties including Panax notoginseng were included in European Pharmacopoeia Recently, Xinxuekang produced by Chengdu Di'ao has also completed its registration in the EU In addition, the FDA registration of Chinese patent medicine has also made important progress The phase II clinical experiment of Fuzheng Huayu tablet developed by Shanghai Modern Chinese Medicine Co., Ltd has also been highly recognized by the US FDA after the US FDA registration of the compound Danshen dropping pill of Tianshili Cross border cooperative R & D is a shortcut to break through the international market of water testing Domestic pharmaceutical companies began to try international cooperation in new drug R & D, promoting cross-disciplinary and even Transnational R & D of traditional Chinese medicine products to become a consensus Nowadays, many domestic pharmaceutical companies have begun to try international cooperation in new drug research and development, and it has become a consensus in the industry to promote interdisciplinary and even transnational research and development of traditional Chinese medicine products It is understood that the clinical research of Fuzheng Huayu tablet is led by the University of California in the United States, with the participation of 9 American clinical centers The operation of the project follows the international clinical research norms, which can be regarded as the starting point of international cooperation of traditional Chinese medicine According to Zhang Boli, the advantages of traditional Chinese medicine lie in clinical efficacy However, clinical efficacy needs to be expressed with scientific data to be recognized by the international community Chinese traditional medicine enterprises should actively seek interdisciplinary and transnational cooperation, and strive for the international discourse power of Chinese traditional medicine Ren Dequan, former deputy director of the State Administration of traditional Chinese medicine, believed that in order for traditional Chinese medicine to enter the world, we must make full use of modern science and technology on the basis of traditional Chinese medicine theory, absorb modern science and technology methods, and use modern research methods, dosage forms and language expressions to let Westerners understand it and accept it The State Administration of traditional Chinese medicine will also intensify efforts in the standardization construction of traditional Chinese medicine, and provide continuous support for pharmaceutical enterprises in scientific research funds, taxes, price protection, bidding, access to relevant directories, etc Industry insiders said that with the rapid pace of internationalization of traditional Chinese medicine, there are still hidden dangers in low added value, trade barriers, intellectual property rights and other aspects At the same time of strengthening research and development, Chinese medicine enterprises should improve the awareness of intellectual property protection, such as patent application, so as to better go to the international market Traditional Chinese medicine pays more and more attention to the dialectical treatment of the whole, treating both the symptoms and the symptoms, adjusting the balance of the body and so on "Facing the challenges of many diseases, especially the complex diseases caused by many factors, western medicine has encountered many difficulties Chinese medicine pays more and more attention to a series of dialectical treatment ideas, such as the whole, treating both the symptoms and the symptoms, adjusting the balance of the body, etc It can be said that the development of Chinese medicine has entered a new period of strategic opportunities " Academician Chen Kaixian, President of China Association of integrated traditional Chinese and Western medicine, told reporters It is understood that the US FDA is organizing experts to study the multi-target therapeutic effect of traditional Chinese medicine Hassanein, a famous liver disease expert of FDA and professor of the University of California, recently came to China to say, "after the success of Fuzheng Huayu tablet test, FDA hired a number of Chinese medicine experts to actively request Chinese medicine enterprises applying for certification to submit Chinese application materials, so as to increase their understanding of Chinese medicine and pharmacology." Some traditional Chinese medicines have successfully entered the mainstream pharmaceutical market abroad Taking Beijing Tongrentang as an example, 90% of its exports of traditional Chinese medicine are proprietary Chinese medicine This century old store has opened 74 retail pharmacies in 16 countries and regions overseas, relying on the mode of "taking medicine with medicine" Almost every store has TCM doctors stationed in it Through TCM treatment business, TCM sales are driven and TCM and TCM successfully enter the international market "Fuzheng Huayu tablet will start more rigorous phase clinical trials as soon as possible It is expected to be sold in the United States as a prescription drug within four to five years " Professor Liu Ping, the inventor of Fuzheng Huayu formula and vice president of Shanghai University of traditional Chinese medicine, told reporters #P ා the lack of "traditional Chinese medicine version" in international standards has hindered the integration of traditional Chinese medicine with international standards At present, traditional Chinese medicine is mostly registered as healthy food in overseas countries and has no drug status as a whole According to the statistics of the State Food and drug administration, the annual sales volume of the world's botanical medicine market has exceeded 20 billion US dollars However, China, as the origin of traditional Chinese medicine, has no corresponding international status In 2012, the export amount of traditional Chinese medicine extracts was only US $1.13 billion, accounting for 48.5% of the export amount of traditional Chinese medicine The export of traditional Chinese medicine and decoction pieces is 700 million US dollars, accounting for only 33% of the export of traditional Chinese medicine Why is it so hard for traditional Chinese medicine to go abroad? "Modernization of traditional Chinese medicine is not easy." Li Daning, former deputy director of the State Administration of traditional Chinese medicine, believes that "traditional Chinese medicine has a unique advantage of multiple targets in clinical treatment, but problems such as backward quality standards, unclear effective ingredients and mechanism of action, and poor controllability also hinder the process of integrating traditional Chinese medicine with the international practice." According to the directive on traditional plant registration procedure issued by the European Union in 2004, pharmaceutical enterprises need to provide at least 30 years of medical history and at least 15 years of use history in the European Union before they can register and enter the European Union market as drugs The therapeutic effect of traditional Chinese medicine has not been recognized by the international standards and the research methods vary from person to person The concentration of traditional Chinese medicine industry in China is not high, there are no flagship enterprises with the scale of 10 billion yuan, and there are few enterprises with the scale of more than 1 billion yuan "Lack of innovation, low level of repetition, small scale, poor industrial concentration and other problems are the main reasons that hinder the internationalization process of traditional Chinese medicine, so it is necessary to establish a scientific standard of traditional Chinese medicine that can meet international standards as soon as possible." Zhang Boli, academician of the Chinese Academy of engineering and President of the Chinese Academy of traditional Chinese medicine, said In addition, the uneven resources and quality of traditional Chinese medicine are not conducive to the formation of its own international standards In recent years, the supply crisis and quality decline of Chinese herbal medicine resources have aroused widespread concern, the reason is excessive exploitation Zhang Boli suggested that traditional Chinese medicine should be listed as a national strategic resource, to strengthen protection, research and development and rational utilization, to cultivate rare and endangered traditional Chinese medicine artificially, to promote the recovery of resources, to make a general survey of traditional Chinese medicine resources, to strengthen the monitoring of traditional Chinese medicine resources and the construction of information network; Strictly control the exploitation of Chinese herbal resources, strictly restrict the export of Chinese herbal medicines and extracts according to the degree of scarcity, and only after meeting the domestic demand can they be exported, and prohibit the export of rare varieties At the same time, we should vigorously promote the standardized cultivation of traditional Chinese medicine, and carry out the large-scale standardized cultivation of key traditional Chinese medicine varieties, national essential medicine catalog and national medical insurance catalog varieties, so as to ensure the sustainable supply of traditional Chinese medicine and ensure the quality and safety of products #P if we want to "internationalize", we should first focus on "modernization" Traditional Chinese medicine has changed from traditional agricultural production to modern agricultural production with gap as the core A number of standardized planting bases of traditional Chinese medicine have been built, forming a combination of traditional Chinese medicine and agricultural development Chinese medicine pieces have entered the era of GMP certification, and large-scale production and mechanized production have replaced small-scale production and manual production, gradually establishing a standardized production and quality control system China's traditional Chinese Medicine Innovation The new system was basically formed, and a number of national engineering centers, technical centers and key laboratories were successively established With continuous efforts, the industry of traditional Chinese medicine is gradually taking shape Then, the road of internationalization of Chinese medicine industry is not smooth Taking the export of Chinese patent medicine as an example, the export share of Chinese patent medicine in the world is relatively low, and more than 80% of the market is occupied by Japan, South Korea and other countries Not only that, Chinese herbal medicines exported abroad are often processed abroad and then sold back to China, and the majority of profits are not in the hands of domestic enterprises In the process of internationalization of traditional Chinese medicine industry, there are many reasons First of all, China's traditional Chinese medicine industry has experienced a fundamental transformation from manual workshop to industrial production, that is, what happened in the 35 years of reform and opening up, and this transformation is still in progress, the relevant industry standards are constantly improving, and the objective gap still exists; secondly, the international acceptance of traditional Chinese medicine is also a process of gradual change, very For a long time, traditional Chinese medicine has not been regarded as a drug by the administrative departments in foreign countries, but tested according to the food standards, which greatly limits the development of traditional Chinese medicine industry in foreign countries In addition, although the vigorous development of global pharmaceutical and health care products industry has brought many potential development opportunities for Chinese medicine industry, more and more technical barriers to trade and traditional Chinese medicine industry have emerged in recent years The inherent short board of the industry has become an obstacle to improve the internationalization level of traditional Chinese medicine in China The rapid development of traditional Chinese medicine industry is fundamentally benefited from the national strategy of modernization of traditional Chinese medicine To continuously promote the internationalization level of Chinese traditional medicine industry, we must firmly grasp the "bull's nose" of modernization of Chinese traditional medicine On the one hand, we must constantly promote the construction of standard system, industrial platform and talent echelon of Chinese traditional medicine industry, and promote the industry's international docking through continuous innovation On the other hand, we need to accelerate the cultivation, participation and leading of international economy in accordance with the "accelerating the cultivation, participation and leading of international economy" proposed by the Third Plenary Session of the 18th CPC Central Committee As required by "new advantages of economic cooperation and competition", actively participate in the formulation of international regulations and industry standards on the evaluation of traditional Chinese medicine, actively strive for the corresponding right of discourse on the premise of ensuring the quality and safety of drugs, and provide more assistance for the Chinese medicine industry to go abroad.