How Chinese patent medicine is accepted by Western Medicine
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Last Update: 2013-09-22
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Source: Internet
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Author: User
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Wang Lian, director of the office of the State Administration of traditional Chinese medicine, responded to the recent ban on the sale of Chinese patent medicines in the UK, saying that China should accelerate the establishment of scientific standards for Chinese patent medicines that are in line with international standards Experts in the industry think that the composition and evaluation system of Chinese patent medicine need to be discussed with the international community To be recognized as a drug by the Western medical community, Chinese patent medicine needs to be elaborated in modern medical language, planted safely, registered internationally and other efforts Traditional Chinese medicine is a supplement in the West Yu Zhibin, deputy director of the Department of traditional Chinese medicine of the chamber of Commerce for import and export of Chinese medicine and health care products, believes that the EU's "directive on the registration procedure of traditional botanical drugs" was launched in 2004 and officially implemented in 2011 The EU has given relevant enterprises seven years of transition time, but none of them passed In fact, the UK's ban is not only aimed at China, but also the Chinese medicine in Japan and the scientific Chinese medicine in Taiwan Chinese patent medicines in China are mainly sold domestically, mainly in Hong Kong, Japan, Southeast Asia and other countries, not many in Europe and America The export of Chinese patent medicine in China accounts for only 0.58% of the total export in the UK, and the ban on the sale of Chinese patent medicine in the UK has little impact on the internationalization process of Chinese patent medicine in China; however, there is a demand for Chinese patent medicine in the UK, and the ban on sale makes the demand for Chinese patent medicine in the UK unable to be fully met "It is difficult to establish the standard of Chinese patent medicine in line with the international standards The philosophy system of Chinese and Western medicine is not the same There is a long way to go to establish the international standard of Chinese patent medicine, but it is ultimately a direction of efforts." Yu said Fu Yanling, Dean of the International College of Beijing University of traditional Chinese medicine, believes that at present, Western medical journals recognize some treatment methods and means of traditional Chinese medicine, such as acupuncture and massage, which are in line with their evaluation principles There are reports in the New England Journal of medicine that Taijiquan has advantages in the treatment of Parkinson's disease At present, western medicine does not regard Chinese patent medicine as medicine, but only as supplement Fu Yanling expressed that the clinical evaluation system of Chinese patent medicine is different from that of Western medicine For example, Liuwei Dihuang price pill, which is explained by traditional Chinese medicine to treat kidney deficiency, has a wide range of indications However, western medicine requires to know exactly what disease to treat and evaluate the curative effect of the medicine according to the name of the disease Kidney deficiency in traditional Chinese medicine and Western medicine are two concepts There is no clear diagnostic standard for kidney deficiency in western medicine Whether the drug is effective or ineffective depends on the test indicators in western medicine, while in traditional Chinese medicine it depends on whether the symptoms are relieved Traditional Chinese medicine can diagnose kidney deficiency according to observation, hearing and inquiry Tinnitus, leukaemia and low renal function can all be symptoms of kidney deficiency However, patients may not have the problem indicators mentioned in western medicine, such as the presence of urine protein and occult blood After taking Liuwei Dihuang price pill, the patients' tinnitus, hoarseness and other symptoms have been relieved, which is effective in the evaluation system of traditional Chinese medicine, but it does not meet the evaluation standards of Western medicine, so Liuwei Dihuang price pill is a health product, not a drug in the western market "We need to use the modern medical language to explain the function of Chinese patent medicine For example, Xiaoyao Pill is well sold in western countries This kind of Chinese patent medicine is liver soothing and Qi regulating, but if it is used to treat depression, then the Westerners will understand and accept it Relevant industry associations should organize a team to study this issue and select several products to explain their functions in the language of modern science " Fu Yanling suggested Enterprises need to apply for strategies to defeat the problem of banning the sale of Chinese patent medicines in the UK in many ways Tian Shuyan, President of Yiling Pharmaceutical Research Institute, pointed out that the industry should be objective about this It is not accurate to say that the total ban is only for some Chinese patent medicines which are not approved by the UK drug regulatory authority and are in circulation in the market "The standards of traditional Chinese medicine and Western medicine are not comparable in themselves." Mr Tian said that traditional Chinese medicine was included in the management of botanical drugs in Europe There are special regulations and guidelines in Europe to manage the registration, safety and quality requirements of botanical drugs When it comes to how the standards of traditional Chinese medicine are in line with the international standards, Tian Shuyan believes that there are two aspects involved, the first is the harmful components of traditional Chinese medicine (including heavy metals and agricultural residues) There is no shortcut to this point Only by means of gap, such as good planting and standardized management of raw materials of traditional Chinese medicine, can we meet the international requirements The second is the definition of the quality standards of medicinal materials In fact, the European Herbal Medicine Commission has a monograph on some of the medicinal materials recognized by the quality and safety of these monographs, all of which have clear quality standards Moreover, the number of traditional Chinese medicine in the monograph is increasing year by year Of course, it has something to do with the continuous progress of traditional Chinese medicine research and the close cooperation between the Chinese government, including the Pharmacopoeia Committee and other institutions in Europe Tian Shuyan told Beijing Business Daily that in early September this year, Lianhua Qingwen, a representative product of compound Chinese medicine developed by Yiling pharmaceutical, began to register in Europe She said that there are still many difficulties in this international registration path, but they started from the source according to the registration requirements of the European drug administration, building gap (drug planting management standard) base of component medicinal materials, CMC (production technology, impurity research, quality research, stability research and other pharmaceutical research materials), GMP (GMP) certification in workshops Quality control and other aspects of active preparation, each break At present, Yiling pharmaceutical has established strategic cooperation with the top domestic research institutes of medicinal materials resources and pharmacokinetics, actively prepared relevant research and data, and conducted detailed consultation with the officials of the drug evaluation committee of the Dutch drug administration on the European registration of compound Chinese medicine From the results of the consultation, it is hopeful that the product will be registered in Europe.
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