Traditional Chinese medicine is staying in Europe

health

Recently, the media have reported the eu traditional medicines programming instructions "on Chinese registered the impact of Chinese export the European Union. To this year on April 30, unregistered traditional medicines can be required to withdraw from the eu market. In fact, many Chinese medicine in China to export enterprise worries about the matter from started years earlier, but for various restrictions, does not have a registered success, whether that means Chinese medicine will completely quit Europe? Standing in "walk" and "left" the crossway, enterprise, industry where to go?

Chinese medicine health products import and export Chambers of commerce, vice President of liu zhang Lin

Originally a good opportunity

In 2004, according to eu in plant medicine legislation and practical application is put in bigger difference, the registered management method is different, the standard is uneven, and traditional herbal medicinal products management measures (with eu drugs 2001/83 / EC) hard to complete registration and other reasons, the European parliament and the European Union in the European Union council in the basis of drug registration instructions, on March 31, 2004 promulgated the 2004/24 / EC instruction, mainly in the directive 2001/83 / EC cannot obtain the drug and formulate marketing authorisation.

2004/24 / EC instruction sets, to 2004 in the eu market years ago... with food/food supplements and herbal products sales of identity to 7 years transition, to April 30, 2011 deadline. In the seven years relevant products, drug registration shall be completed. On April 30, 2004 to October 2005 during the first 30 days, then no longer listed products enjoy seven years of transition. Transition period, the traditional medicine for unregistered, will exit the eu market. And to comply with the eu related food safety regulatory plant medicine (or herbal) products, can continue to according to the food/food supplements management.

2004/24 / EC instruction for Chinese medicine, in the eu as a drug to register provides a good opportunity, once registered successfully, can enter the mainstream of the 27 eu nations pharmaceutical market, even can enter medicare directory. In addition, China's current national many proprietary Chinese medicine in America and Europe as food management, the eu traditional medicine simplified registration implementation, will be deployed to the traditional Chinese medicine product, one kind of affirmation in the eu, will register of TCM products in other countries play demonstrative effect registered, promote the internationalization process of traditional Chinese medicine.

Although decrees issued, the parties are highly valued, due to various reasons, at present our country still no case was proprietary Chinese medicine product complete registration. Even if the eu now has not yet complete list must register of traditional medicine, but the disease could be used to establish the diagnosis will be strict management of proprietary Chinese medicine. If does not conform to the eu food regulations, these proprietary Chinese medicine will exit the eu market. At present, the British regulators have notified expire on imports of proprietary stop as Britain health departments determine the proprietary Chinese medicine can use by registering the related plant medicine without registration. So, the Chinese traditional Chinese medicine clinics will face "a lack of medical drugs" for traditional Chinese medicine, negative situation internationalized caused heavy loss.

Enterprise's lack of declare enthusiasm

The European Union is the biggest except outside China plant medicine market, has about 60% more eu citizens used traditional plant medicine, the size of the market has reached $7 billion, in recent years, more than 6% growth next year. The European Union is also the main market of Chinese materia medica exports. By 2010, China export total for the eu TCM, accounting for approximately 2.5 billion dollars of Chinese materia medica exports of 14%. This year, China 1 ~ 3 months to the European Union 8949 million Chinese exports reached year-on-year, 45.6%. One 576 million us dollars, proprietary Chinese medicine exports increased 104% year-on-year.

Faced with such important export market and Chinese medicine of traditional Chinese medicine "becomes" opportunities, and not all businesses are indifferent. Beijing colleague, tianjin TianShiLi, lanzhou Buddha Keats, guangzhou qixing, jiangsu Yangtze pharmaceutical enterprises have been or are being prepared for the Chinese medicine drug registration or simplified registration application. However, want to mobilize more enterprise into this job, still exist difficulties.

Enterprise to cost-income expectations low. At present, China's export eu proprietary Chinese medicine, but these products without entering the eu countries products from the market, so drug mainstream, market scale doesn't see varieties. On the other hand, according to eu related regulations, export drug regulations of the eu market by eu GMP pharmaceutical must, but our country GMP and the European Union has not yet mutual recognition, both exist specific requirements differences. This means that access to European markets, to Chinese companies need to prepare two sets of GMP system, to accord with the eu regulations still need factory GMP transform and accept eu spot checks. Therefore, "small market, big input" situation makes the enterprise to carry on the traditional medicine registered positive is not high, lack of access to European market power.

Our enterprise to meet decrees for the traditional use fixed number of year requirements. According to 2004/24 / EC instruction, apply for simple registered traditional medicines, and must meet "should have literature or expert evidence that this herbal drugs before the date of filing, the use of at least 30 years in the eu history, including at least 15 years within the provisions of the use of history". China's exports more than Chinese food supplements, and mainly as a Chinese TCM clinic in long-term use of, lack of products and applications in local reported. So, for eu countries 15 years using historical proof, become our proprietary products in the eu registered and a barrier.

Chinese enterprises lack of eu traditional medicine quality standard research. According to eu regulation, the quality of export drugs must conform to the eu to pharmaceutical import requirements pharmacopoeia, eu nations drugs management agencies will be according to the European pharmacopoeia quality appraisal. If the imported drugs were not eu pharmacopoeia monographs, criterion with eu member states pharmacopoeia shall prevail. At present, more than European pharmacopoeia monographs medicinal herb for Europe to the east, local monographs herbal products less. Therefore, China pharmacopoeia of herbal products with the European pharmacopoeia differences between the requirements. Our country enterprise often only research of their standards, not putting energy research eu pharmacopoeia.

"Icebreaker" need government support

2004/24 / EC instruction for the implementation of Chinese materia medica industry, it is not only challenge, and opportunity. Although prophase work was not good, our country enterprise can still use the traditional herbal medicine for instructions for some special provisions, a proprietary Chinese medicine can access to European markets through a simplified registration.

Product registration though is the enterprise behavior, but expect the government can give enterprise more from the policy level, jointly promote the Chinese medicine support go abroad.

The government shall establish a departments should participate in coordination team, coordinate and promote departments related work of proprietary Chinese medicine eu registered. And establish communication mechanism, to address common eu registered related with proprietary Chinese medicine pharmaceutical management, quality standards and trade issues. Although the government is not registered subject, but should actively support enterprise registration activities, for administrative management, technology and quality standards to give policy and financial support, by setting up a special funds for prior registered successfully, proprietary Chinese medicine products according to the proportion or a fixed amount gives support, so as to promote enterprise actively registration. Domestic and international business association and scientific research units will participate actively and promote eu registration. Proprietary Chinese medicine

Traditional Chinese medicine internationalization is long-term development strategic objectives and concrete implementation product internationalization research and development process, should adhere to the "three equal" strategy. Firstly, guarantee existing channels. Traditional Chinese medicine in foreign to the form of food and functional health products, should be stable and development sales this market; Secondly, with over-the-counter forms promotional and sales, actively promote traditional Chinese medicine into conventional medicine market; Thirdly, with technology and professional marketing mode, go clinical medicine developed countries promote road, by the drug approval, into developed countries regulations prevailing market of prescribed drugs. At the same time, but must take the impelling our country medicine into countries, especially the work the pharmacopoeia enter the United States pharmacopoeia and European pharmacopoeia and British pharmacopoeia and Japanese pharmacopoeia monographs of drugs. In addition, still should notice the establishment of "China standard", to let more medicine, national identity, after first medicine medical with medicine, so as to promote healing in the international development of traditional Chinese medicine.

The eu traditional medicines for our Chinese medicine international registration is an important opportunity, but the situation quite stark. Need each government and enterprise jointly with the eu, send force registered as an opportunity to traditional medicine in China, so as to further promote the internationalization of Chinese medicine.

Net friend voice

Close ear: Chinese medicine will do more than just out of the country, more important is to expand the domestic market. Out of the country? Why? Don't just to tell others, foreigners with Chinese medicine in? At present, the domestic doctor also have a special liking to western medicine, if Chinese native medicine in domestic market can add 1 times, its benefit is very optimistic. Our priority is to improve the level of TCM study, play the advantage of traditional Chinese medicine, make compatriots specific widespread, safely use. After all, the Chinese to their own cultural more understanding of the world, the Chinese population of 1/5. If even the nation is difficult to generally accepted, how to let a foreigner to accept?

Unsung hero: as a professional personnel engaged in pharmaceutical analysis, I felt responsibility is significant. I think, obstruct Chinese medicine to enter the international market of the most fundamental reasons is China's traditional Chinese medicine quality control technology is very backward. See China pharmacopoeia 2000 (a) content right, with the real accord with international standard quality standards have several? And most of the medicines and preparations have content determination of even. So how can the quality standard of convincing. Want to let a Chinese medicine go abroad, must use advanced and developing analysis technology, perfect quality standard of traditional Chinese medicine.