Chinese medicine goes to the sea, EU meets the wall and pushes domestic standards to upgrade

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 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 brands are listed 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 the 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 The internationalization of traditional Chinese medicine faces so many difficulties and challenges 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.