Traditional Chinese medicine research and development innovation are looking forward to more breakthroughs 
 
 
09:11 on November 6, 2014 
 
 
Business club on November 6

    On October 21 at the 18th annual Beijing international biomedical industry development on the BBS, Austin frank Douglas at the opening ceremony, director of the institute of biological innovation for research in the field of TCM in China, he said: "Chinese medicine more and more get the attention of people, it is more and more combined with modern technology, and become a modern industry, become a truly modern sense of a medicine. Hope that through this exchange, China will be able to further progress in these areas."
 
    In the subsequent "science and technology innovation of great variety, the road of internationalization" of the "seminar of industry transformation and upgrading of traditional Chinese medicine" points on the BBS, the Chinese academy of engineering academician zhang bl, the drug registration division of China's state food and drug administration, Chinese medicine, deputy director of the national medicine place hai-nan wang, Beijing university of Chinese medicine, Chinese medicine, dean of the school of Lin Rui chao deng made a keynote speech respectively, the necessity of the research to the modernization of traditional Chinese medicine (TCM), the new progress and traditional Chinese medicine research and development, innovation, and analyzes the problems such as international marketing.
 
    Progress was made in traditional Chinese medicine modernization
 
    Zhang bl academicians think, is the trend of The Times and development of Chinese medicine should speed up the study of traditional Chinese medicine (TCM) modernization progress.
 
    The world health organization (who) in the "meet the challenges of the 21st century" in the report pointed out that the 21st century medicine should not be to disease as the main research fields, and to human health as the main direction of medicine, medical purpose is to discover and develop people's ability to self health.
 
    "Per capita medical expenses is the 1/3 of the United States, the poor foundation, weak foundation and uneven development between urban and rural areas, how to satisfy a population of 1.3 billion, under the existing conditions of basic health care is a very complicated problem, the solution is dependent on the traditional Chinese medicine," zhang bl academicians pointed out that "combine traditional Chinese and western medicine is the strength of China, also reflected the characteristic of China. The current medicine research and development is the trend of multiple drug development model, the production of traditional Chinese medicine research about one-third of the total output value of drugs, drug firms abroad in Chinese herbal medicine market. Also study traditional Chinese medicine, the use of good Chinese traditional medicine, make traditional Chinese medicine in the service of society, is the world's major demand for traditional Chinese medicine medical development."
 
    Since 1996, Chinese traditional medicine research and development in our country have been exploring research and development, production technology and the international community, to build first-class platform, study more new drugs, reform more big medicine, form the industrial aggregation, many new progress has been made in study of traditional Chinese medicine modernization.
 
    First of all, the level of research of traditional Chinese medicine in China gradually increase. From simple laboratory conditions of 20 years ago to now can and internationalization level comparable to advanced environment, from our country to build components of traditional Chinese medicine development platform depots found that more than 50 lead compounds to the chemical group, all reflect the improvement of traditional Chinese medicine research in China. Second, Chinese medicine pharmaceutical technology and equipment to upgrade. The development of traditional Chinese medicine (TCM) to establish a concept that Chinese traditional medicine quality improvement must rely on production technology and equipment innovation. Many large enterprises put great effort in the pharmaceutical technology, there are also many enterprises pharmaceutical equipment with the intellectual property rights. Third, traditional Chinese medicine to speed up the internationalization progress. Compound danshen dropping pill, : capsules, centralizer huayu tablet in the clinical research of developed countries such as the United States, the European Union, have made great progress. Fourth, SCI papers related to quantity and proportion of traditional Chinese medicine.
 
    Traditional Chinese medicine registration should focus on four big problems
 
    In recent years, with the rising of Chinese medicine pharmaceutical ShenBaoLiang, followed by traditional Chinese medicine registration problem has become a hot topic of enterprise. Traditional Chinese medicine registration should pay attention to what issues? In points on the BBS, hai-nan wang has analyzed the Chinese traditional medicine registration should pay special attention to several questions.
 
    Hai-nan wang believes that to ensure the traditional Chinese medicine registration process well, first of all, in the process of research and development shall be according to the law of development. "According to the law of development and mainly reflected in the inheritance and innovation, don't hidebound, should inherit not old, carrying forward and carrots, to optimize the prescription in clinical practice, confirmed by clinical experiments curative effect, and advocates the secondary development of older drugs, and in have clinical showed an effective agent for optimization, creating large variety".
 
    Next, should pay attention to the clinical value. Hai-nan wang believe that drug is a special commodity, eventually to solve clinical problems, therefore, from research and development is very important for the beginning of the clinical value and to use scientific methods to reveal the safety and efficacy of new drug of TCM. For clinical drug derived from clinical, service, traditional Chinese medicine (TCM) as a drug should follow this rule.
 
    Third, we should analyze the indications. Hai-nan wang revealed that, in recent years, in terms of analysis of the indications of Chinese traditional medicine, enterprise have very big difference. "Research and development of traditional Chinese medicine new drug of the last century, feeling giving a person is often universal Chinese traditional medicine, can cure anything. In fact is not the god of medicine, analyze indications, find out the most useful points out research and development, this is very important in research and development strategy."
 
    Fourth, must complete the entire control. Hai-nan wang said: "it is the characteristic of Chinese medicine, plant medicine. Traditional Chinese medicine (TCM) is a resource dependent, also need to manage all the way, regulation should also be appropriate follow up according to this characteristic. The future new declaration, the first thing to provide authoritative third-party resources evaluation report, rather than to wait until after the project is approved, industrialization, alternative resources drying up. In this way can guarantee the sustainable development of traditional Chinese medicine resources, proprietary Chinese medicine varieties."
 
    Differences between the research power overseas promotion
 
    When it comes to traditional Chinese medicine registration, inevitably involve the overseas registration problem of Chinese traditional medicine. October 22 points on the BBS, thies Zhang Hailei pharmaceutical co., LTD President of "herbal medicine" in question has carried on the detailed interpretation of Chinese and foreign registered similarities and differences. Zhang Hailei said that China has no concept of plant medicine, but is called natural medicines, derived from medicinal plants, minerals, accord with modern medical theory. Natural medicines including animal medicine and mineral medicine, contains more than the plant concept. And European plant medicine is herbal medicine and herbal extracts, their portfolio of compound preparation from medicinal plants.
 
    Overseas registered in Zhang Hailei view, plant medicine, it should be noted in terms of standard "plant sources close to conform to the standard of chemical medicine, even there is a clear, at least know one or a kind of effective components, and accurate quantitative, use of modern testing technology for its effective component testing." Zhang Hailei said, "in general, now plant medicine conforms to the Chinese herbal medicine production quality management standard, pharmaceutical production quality control standard for pharmaceutical non-clinical research and the quality control standard for pharmaceutical clinical trials and the quality control standard for four kinds of specifications, is likely to get the possibility of overseas plant medicine registration."
 
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    "In terms of regulation, department of China is the food and drug administration regulation, the United States by the FDA, the European Union is the EMEA." Zhang Hailei, according to the American plant medicine registration has a special point, if the drug is dietary supplements, do as the dietary supplement health education act, dosage form can powder, tablets, capsules, etc. But if the medicine in the form of registered in the United States, is very strict. New drug application if it is a prescription drug without a medical history, other countries have no medical history in the United States, approved can enjoy 3 years or 5 years of market monopoly. Simplify the eu registered, also called the traditional application, can reduce requirements for clinical trials, to a clinical trial is not required, if registered in plant medicine form has two procedures, one is centralized decentralization program, centralized once approved, the eu can be listed. If the separation of the program may apply in one eu member states, after the mutual recognition process, on the basis of 210 days to add 90 days, the actual registration time need a total of 300 days.
 
    "Traditional Chinese medicine in modern science and technology and the impact of market economy is facing unprecedented opportunities and challenges. We need not only in technology, constantly improve the registration method, should also strengthen the communication with the outside world, rather than simply introducing foreign plant medicine, should also help Chinese enterprises to go out and achieve win-win situation. The advantage of the inheritance of traditional Chinese medicine and the characteristic, the traditional theory of traditional Chinese medicine combined with modern science and technology, the traditional Chinese medicine with modern science and technology research and innovation, make our country's traditional Chinese medicine drug discovery in the international leading level, if these can be achieved, the innovation of new drug of TCM also there will be a real breakthrough." China institute of traditional Chinese medicine academy of sciences, said Chen sl.
 
(article source: journal of science and technology)