EU traditional herbal medicine registration directive brings opportunities for the internationalization of traditional Chinese Medicine

Business news on July 11 how to make a traditional Chinese medicine registered in the European Union, and enter the local mainstream medicine market as a medicine, and sell it to Europeans? Scholars, business representatives and relevant government officials from the Chinese traditional medicine industry have recently gathered in Lanzhou, Gansu Province, Northwest China to discuss this issue, so as to further promote the internationalization of traditional Chinese medicine, a treasure of the Chinese nation Gansu is the largest province of Chinese herbal medicine artificial planting area in China, with the planting area of about 2.5 million mu Lanzhou foci Pharmaceutical Co., Ltd., the province's "China Time-honored Brand" pharmaceutical company, submitted an application for registration of a traditional Chinese patent medicine to the Swedish National Drug Administration, a member of the European Union, in June this year and was accepted This is the first time that Chinese patent medicine has applied for drug registration in the EU The EU issued the EU traditional herbal medicine registration directive in 2004, which provides for a "simple registration" procedure and sets a seven-year sales transition period for herbal medicines that were then in use in the EU By April 30 this year, the seven-year transition period has expired, and this directive has been formally implemented Fosci applied for drug registration in the European Union, which aroused the attention of Chinese traditional medicine industry to the EU registration of traditional Chinese medicine While the media are concerned about the success of fosci pharmaceutical registration, they are also questioning why no case of Chinese medicine has been registered in the EU in the past 7 years Wang Guoqiang, director of China's State Administration of traditional Chinese medicine, said: "because there is no successful registration of Chinese patent medicine in the European Union, Chinese patent medicine will not be able to continue to be sold in the European Union in the short term, but pieces and extracts with a large export share can still be sold in the form of food or food supplements." Previously, Chinese patent medicines, like Chinese herbal pieces and extracts, were sold in the EU in the form of food or food supplements Due to the lack of recognition of drug identity and access to the mainstream pharmaceutical market, the market share of Chinese patent medicine in the EU has been very small According to Wang Guoqiang, in 2010, the export volume of Chinese traditional medicine to Europe was 250 million US dollars, of which only 4% was Chinese patent medicine, about 10 million US dollars Although in the past seven years, for various reasons, none of the traditional Chinese medicine has passed the EU drug registration, most Chinese people who came to Lanzhou to discuss the EU registration of traditional Chinese medicine believe that the EU traditional herbal medicine registration directive objectively provides opportunities for Chinese medicine to accelerate the pace of internationalization Wang Guoqiang said that compared with the requirements of the European Community directive on the registration of human drugs, the "simple registration" procedure stipulated in the new directive greatly improves the possibility of the registration and sale of Chinese patent medicines in the form of drugs, and objectively provides an opportunity for Chinese traditional medicine products to enter the EU market in the form of drugs At present, the EU is considered to be the world's largest market for botanical drugs other than China On the surface of EU registration, traditional Chinese medicine is the recognition of drug identity, but behind it is a huge potential market Sun Yu, deputy general manager of foci pharmaceutical, said that if foci's Chinese patent medicine can be registered in the European Union, enter the regular drug channels and open the market, its sales volume is expected to exceed the current total export volume of Chinese patent medicine to Europe In addition, American botanical drugs, which are concerned by the world, are deeply influenced by Europe in drug research, management and market It is generally believed that the success of EU registration will open a convenient door for Chinese medicine to enter the U.S market, and will have a positive and far-reaching impact on the future market sales in North America and even the world "It is an inevitable trend for Chinese medicine to go to the world and enter the international market." Wang Longde, academician of the Chinese Academy of engineering, said, "whether Chinese medicine can gain market access in Europe and the United States as a drug and enter the international market is one of the key issues in the internationalization of Chinese medicine, and also the focus of our long-term attention." Sun Yu said that if the registration in the EU is successful, fosci pharmaceutical will not only set up a sales center in the EU, but also organize experts of traditional Chinese medicine to exchange academic knowledge, train sales personnel, and promote traditional Chinese medicine, which is undoubtedly conducive to the internationalization of traditional Chinese medicine Although the EU traditional herbal medicine registration Directive provides an opportunity for traditional Chinese medicine products to enter the EU market in the form of drugs, it is still a long way to go for more traditional Chinese medicine, especially the complex compound traditional Chinese medicine registered in the EU to enter the mainstream pharmaceutical market as a drug Zhu rongzu, general manager of foci pharmaceutical, said that it is not easy to tell Europeans about the efficacy, safety and ingredients of traditional Chinese medicine It requires a huge amount of scientific research investment, a large amount of human and financial resources and a great risk This is also an important reason why no case of traditional Chinese medicine has been registered in the EU in the past seven years However, fosci pharmaceutical, which has accumulated experience, is now expected to achieve a breakthrough in EU registration of Chinese traditional medicine Sun Yu said frankly that with the increasingly fierce competition in the domestic market, the price of patent medicine has been difficult to rise, while the cost of raw materials, labor and transportation is constantly rising, so there is a broader space for going out For example, the ex factory price of the drug, which was applied for EU registration, is still the price five years ago, and the price of raw materials has already doubled Chinese medicine professionals who participated in the discussion of EU registration strategies for traditional Chinese medicine believe that promoting the internationalization of traditional Chinese medicine is conducive to the upgrading of the whole industry, and the upgrading of the industry can make traditional Chinese medicine better go to the world In this interactive process, in addition to the efforts of enterprises themselves, the government should also give active support Wang Longde said that at present, China's export of traditional Chinese medicine products is still dominated by low value-added raw materials such as traditional Chinese medicine, decoction pieces and plant extracts, which is not commensurate with China's thousands of years of traditional Chinese medicine and the status of a country with large resources of traditional Chinese medicine We look forward to making good use of the opportunity provided by the new EU directive to realize the brand of traditional Chinese medicine in the international market and the return of its due value as soon as possible.