European Union of traditional Chinese medicine meets the challenge of overseas development and forces the upgrading of standards

Although the EU market is not the main overseas market for Chinese patent medicines, a statement by the MHRA poses a potential threat to the overseas expansion of Chinese patent medicines In order to further help people purchase and use safe herbal products, unregistered herbal products will be banned as of April 30, 2014, according to the UK notice The national Han Office of the people's Republic of China recently approved the cooperation of Shanghai University of traditional Chinese medicine and Georgia regins university to hold Confucius Institute of traditional Chinese medicine This marks the establishment of the Fourth Confucius Institute of traditional Chinese medicine in the world and the first Confucius Institute of traditional Chinese medicine in the United States Wu Jingwen, a former official of the permanent mission of China to the United Nations Educational, scientific and cultural organization and head of the international exchange and Cooperation Office of Beijing University of traditional Chinese medicine, believes that under the circumstances that no Chinese patent medicine in China has passed the EU Directive on the registration procedure of traditional botanical medicine and the United Kingdom has started to ban the sale of Chinese patent medicine in China, it is a new idea to consider cultural communication to make Chinese medicine go global, People in the industry think this is a shortcut Chinese patent medicine appears in the name of food and health care products in the international market So far, no case has entered the international mainstream medicine market as a prescription medicine Compound Danshen dropping pill, a Chinese patent medicine, has entered the clinical trials of the US Food and Drug Administration (FDA), which has not been passed for 13 years No Chinese patent medicine in China has passed the EU's registration procedure directive for traditional botanical medicine, and the UK has banned the sale of Chinese patent medicine     It is understood that western countries use the molecular analysis method of Western medicine to analyze the components of Chinese patent medicine The components of traditional Chinese medicine are complex, so it is difficult to know what ingredients play what effect, what relationship among various components, etc Wang Guobao, deputy general manager of Beijing heliantang Pharmaceutical Co., Ltd., said: "western medicine and traditional Chinese medicine have different philosophies, and the way of thinking of treatment is also different According to the Western way of analysis, it's possible that Chinese traditional medicine will be overthrown again " Traditional Chinese medicine is an important strategic economic resource Confucius Institute of traditional Chinese medicine is also driven by economic interests Wu Jingwen suggested that to solve the problem of the export of Chinese patent medicines in the EU, top-down cultural diplomacy and overall diplomacy are needed, and the Ministry of Commerce, the State Administration of traditional Chinese medicine and other joint efforts are needed Although the European market is not the main overseas market of Chinese patent medicines, a statement from the MHRA has posed a potential threat to the overseas development of Chinese patent medicines Recently, the UK issued a notice saying that in order to further help people purchase and use safe herbal products, unregistered herbal products will be banned from sale from April 30, 2014 In the published list, several Chinese brands of traditional Chinese medicine are on the list In fact, at present, there is not a Chinese patent medicine product registered successfully in the UK "Registration fees are expensive, it is difficult to declare, how to use data to speak, and how to explain the safety of traditional Chinese medicine to Westerners in a way that they understand are all the challenges we are facing in the modernization of traditional Chinese medicine." Xu Ming, vice president of China Chamber of Commerce for import and export of medical and health products, told the first financial daily After April 30, 2011, the European Union began to implement the traditional herbal medicine act If it is not registered in the European Union, it cannot be sold as a traditional herbal medicine in the European Union "Chinese medicine basically enters the EU market according to the identity of food, and the EU has strict regulations on the entry of food According to the EU law, the so-called health functional food containing medicinal ingredients cannot be sold as food and must be registered as a traditional herbal medicine The UK is now in full compliance with the EU's traditional law, but more clearly Xu Ming told reporters The domestic market is still the largest for the enterprises producing Chinese patent medicines Data shows that last year, the domestic market sales reached more than 410 billion yuan, and the sales volume of Chinese Herbal Pieces exceeded 500 billion yuan "We export very little, we don't sell in the European market, so we don't study the EU system very much." Song Qing, general manager of Cr 39, told reporters At present, only Chengdu Di'ao's Xinxuekang capsule has been successfully registered and approved for listing in the Netherlands, becoming the first and only therapeutic drug entering the EU in China More companies fall outside the EU's high threshold In addition, enterprises with large actions, such as Tongrentang (600085 SH), are also mainly located in Australia, Canada and Southeast Asian countries "But it still has a great impact on us, because there may be some chain effects For example, the United States and Southeast Asia are our major overseas markets, especially Southeast Asia We fear that other countries or regions will follow the EU's example " Xu Ming said "Due to cultural differences, evidence-based learning is adopted in foreign countries, and data is needed to speak But we say that the toxicity of the poisonous medicinal materials has been greatly reduced after being processed If we can't just say that, we need to take out experiments and data " Some industry analysts said However, "we cannot provide 15 years plus 30 years of safe use data, that is, evidence of 30 years of safe use outside the EU and 15 years of safe use within the EU." Xu Ming said The Dutch drug evaluation agency once said that the key to the successful registration of di'aoxinxuekang is to provide product safety reports, such as detailed data reports on pesticide use, foreign substances, heavy metal content, etc However, to provide these data, not only a lot of time is required to prepare, but also the cost is very high, which is one of the reasons why some enterprises are reluctant to register Xu Ming said that for each single product, the registration fee is not equal to the profit that may be brought in the near future "A product may cost more than 10 million to register, but in more than 20 countries in the European Union, there are only tens of thousands or even thousands of dollars in sales, and the cost doesn't know when it will be recovered." Xu Ming told reporters In recent years, the problems of excessive agricultural residues, illegal addition of components and labeling of toxic components in Chinese patent medicines have become the focus of public attention "External backwardness does not cure the root cause The key lies in internal improvement There are so many difficulties and challenges facing the internationalization of traditional Chinese medicine First of all, we should practice our internal skills well, make our standards conform to the international standards, and effectively improve the quality " Xu Ming said.