Traditional Chinese medicine has not been succeeded in registering And then enter European Union to nearly become " It is impossible "
The time in 7 is not short, but still can not let traditional Chinese medicine fulfil the zero breakthrough in European Union, this result is not only unexpected, make people distressed even more. Though the chamber of import and export trade of medical health product in China is still in continuing communicating with European Union, but traditional Chinese medicine will face quiting listing in European Union in an all-round way seem difficult to avoid. It is a painful lesson that no traditional Chinese medicine can finish registering in European Union during the transition period of 7. The expert points out, after April 1, resumed the normal registered procedure, mean the registered cost of a section of traditional Chinese medicine is surged, increased from left and right sides of 10 million yuan to 1 billion yuan. When the time comes, traditional Chinese medicine enters European Union to nearly become " task that it is impossible to finish " . Do not have battle European Union planned to register to fight: If, Chinese enterprises have not obtained the legal identity to do the best in European Union for traditional Chinese medicine in the twinkling of an eye of snap of the fingers of 7 years, not also really a little worthwhile. But the one that can't deny is, while European Union register traditional Chinese medicine, the domestic medicine enterprise feels after knowing after belonging to. China medical Deputy Chairman of health product chamber of import and export trade ZhangLin Liu claim " traditional the intersection of plant and medicine register the intersection of procedure and order " just issue, " 2004, everybody thinks that there are 7 years, but up to 2009, no of traditional Chinese medicine enterprise will file an application. Later, under the circumstances that the association of dealers of the medical insurance held the calls of emergency meeting and relevant government department many times, last year, include Tongrentang Chinese Medicine-Since 1669, the intersection of Guangzhou and strange star and kind 3 the intersection of medicine and enterprise these, Buddha of Lanzhou, set about work declared to European Union to plan. The day before yesterday, reporters sent a telegram to the above-mentioned 3 medicines enterprise respectively, but the answer received was all on material preparatory stage. "If want to succeed in registering in European Union, enterprises can't fight and have no battle prepared, so the company should screen to its traditional Chinese medicine variety, look for the products of European Union's relatively easy acceptance. Prepare the relevant declaration material after confirming the products, can be said to be a great project. " The relevant person in charge of Tongrentang Chinese Medicine-Since 1669 Company explains. What merits attention is, in the above-mentioned 3 medicines enterprise, Buddha in Lanzhou has been considered to be the company most likely marching toward European Union threshold kindly. It is reported, Buddha's kind pharmacy has 5 kinds of traditional Chinese medicine to plan to register in European Union under command, including kind concentration Chinese angelica pill of Buddhism,etc.. Among them, " concentrate Chinese angelica pill " Register in traditional medical herbs of European Union, apply to already enter, dash for stage. But soon " Register the procedure order " Time limit come already,have still kindly Buddha for notice passed to register. Loss of facing the cost and booming is enormous: Traditional Chinese medicine has quited listing and brought disaster to enterprises all the time, European Union is the largest market of plant medicine in the world, annual sales amount is tens of billions euro, account for above world plant's medicine market share 40%. If has given up this market, losses are enormous for traditional Chinese medicine enterprise. An insider points out: "Perhaps someone thinks, annual sales amount in European Union of Chinese medicine is just about one or two ten million dollars now, account for whole traditional Chinese medicine export proportion to be relatively little, even if export mind either, this wrong idea. If Chinese medicine turn dark family into in European Union, that whom traditional Chinese medicine export loud to fall back. " It is reported separately, it is simple and easy after registering the good opportunity to lose by mistake, traditional Chinese medicine enterprises want to give its medicines to apply for the legal identity, boom facing the cost the predicament. Mr. Li engaged in medicines and register the business for a long time has calculated an account, at present, it is probably 10 million yuan through the simple and easy expenses that register in traditional Chinese medicine of European Union, the large and medium sized medicine enterprises can all bear. After 2011 years, should register and need to spend about 1 billion yuan through the standard of European Union medicines. Before the application for registration, Chinese enterprises must upgrade the production facility in order to authorize through GMP of European Union first, it varies from 10 million yuan to several ten million yuan to cost; European Union medicine supervises the department to look over and confirm, nearly need 3 million yuan to the production scene; It applies for, needs to carry on clinical trial to file, one is probably 10 million yuan, two issues and three are 30 million yuan and 80 million yuan respectively, the cost of four issues is among 100 million -300 million yuan. Experiment,etc., it costs about to be 1 billion yuan about always in addition. That is to say, if has not passed before April of this year and registered, it will be extremely difficult in the future. What furthermore let people worry is, traditional Chinese medicine quits listing in European Union and involves the Chinese medicine trade. As far as reporter know, the Chinese traditional Chinese medicine employees in Europe are about 100,000 now, if still there is not traditional Chinese medicine that succeed in registration in 2011, these personnel or facing the unemployment. Should discriminate against traditional Chinese medicine to the great limit: The association of dealers proposes starting with in many ways since under the circumstances, traditional Chinese medicine trade needs making out the method which deals with European Union's great limit badly. The chamber of import and export trade of medical health product in China tells reporters, for this reason this association of dealers has also specially done subject research. The association of dealers of the medical insurance thinks, should start with in many ways in the future, could push traditional Chinese medicine to the world. "First of all, our country should utilize mechanism and European Union of World Trade Organization to carry on the negotiation and non-discrimination principle while making on the regulation, insist on demand " whether traditional the intersection of plant and medicine register the intersection of procedure and order " 2004 simplify, register, lengthen until 2019 transition period. " Secondly, persuade within the territory of strengthening European Union. Learn the news that the federation offers according to the whole Europe traditional Chinese medicine, the organizations of traditional Chinese medicine trade of countries such as Britain, Holland, Italy,etc. have greater influence. Want, strengthen the intersection of world and traditional Chinese medicine, learn federation, World Federation of Acupuncture--Moxibustion Societies with the intersection of China and medical the intersection of health product and the intersection of chamber of import and export trade,etc. and cooperation that trade organizes in European Union, promote persuading and dialogue within the territory of European Union, influence the relevant decision authorities of European Union from inside. In addition, will strengthen the Central European standard and authorize cooperation. According to the stipulations of European Union, once medical herbs enter medical herbs monograph and medical herbs catalogue (not announce yet at present) ,It declare it materials than declaration materials that is simple and easy for application for registration but also " Simplify " ,Needn't offer the certificate or documentary evidence that this product is sanctioned going on the market in the other countries, have record and identification sold in European Union in 15 years, and the security literature is summarized and expert's report. Strengthen to promote units such as the national pharmacopoeia committee,etc. and European Union, Britain, France,etc. to make the cooperation of traditional Chinese medicine decoction pieces monograph, strive that there are medical herbs monograph that 50 pieces of traditional Chinese medicine decoction pieces enter European Union, Great Britain, France within 5 years. The big limit delays having no resolution Britain gives in: Full of uncertainty at the same time in the future, should promote the extract manufacturing enterprise of domestic traditional Chinese medicine according to European Union's medical herbs market demand, choose suitable traditional Chinese medicine to draw article kinds, apply to pass the officinal adaptability authentication of Europe of raw materials medicines to the European medicines quality administration bureau, obtain the officinal adaptability certificate of Europe, sell legally directly in the capacity of medicines raw materials. The relevant government department must lead and support key enterprises to register in European Union through Chinese medicine; Confirm that supports assortment and project especially. Promote the main European Union's relevant research in enterprises and our country The unit cooperates, direct against the concrete requirement for quality of traditional medicines and quality control of European Union, launch relevant research work, solve the key problem of technology that traditional Chinese medicine European Union registers. As to relevant research, such respects as the relevant department should set up from the policy are supported especially. The reporter learns, the negotiations of association of dealers of the medical insurance and European Union have already made some results. News claims, British Ministry of Public Health plans to make some concessions, a doctor make, register the registration procedure obtaining employment for the medical herbs products of those supply before this, medical herbs teacher and Chinese medicine doctor registering can still continue using the generic medical herbs products, this makes traditional Chinese medicine enterprises see that does not need to register the hope of entering Britain even European market. However, European Union registers " great limit " to traditional Chinese medicine The requirement delayed, has not replied, this let future in European Union of traditional Chinese medicine full of uncertainty.
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