Traditional medicine of the Chinese nation has thousands of years of history, cultural heritage, to Europe also have hundreds of years. But in 2011, 1 April, Chinese medicine in Europe will encounter either collapse, or fully armed underground historical choice. Belgium International Medical Center Chairman Professor Lin Kuo-ming said: "the situation is very critical. as of now, there is not a case of traditional Chinese medicine officially registered in the EU. From next year on 1 April, the practice of traditional Chinese medicine in Europe will be confronted with a gun no bullets, i.e. There is no hassle of traditional Chinese medicine. ”
March 31, 2004, the European Union enacted the traditional plant medicine registration procedures directive. The directive stipulates that in the EU market sales of all plant medicine must follow this new statute registered, get listed permission to continue. At the same time, the directive provides for a 7-year transition period, allowing for food and other identity in the EU countries sales of herbal product sales to March 31, 2011. At present, most of the EU market for herbal medicines to food, health care products, plant medicine raw materials or farmers in the form of Deputy local products. But the 7-year transitional period is coming to an end, the EU is still not formally registered, why?
EU the traditional plant medicine registration procedures directive, traditional herbal remedies before the date of filing, "at least 30 years of pharmaceutical history, including within the EU for at least 15 years of history." History proves that the traditional application carried out according to the published literature, expert reports and customs import and export text records also belong to the supporting documents. Professor Lin Kuo-ming said: "for products in the EU market with over 15 years of experience in the use of history to prove difficult. "Some in the Chinese Pharmacopoeia recorded more than 15 years, non-toxic ingredients, are still widely used in classical Chinese medicine, such as Liu Wei di Huang Wan, Wuji baifeng Wan, as early as 1995, before entering the EU market. However, together with ren Tang this century-old shop can offer in the EU market with over 15 years of experience in the use of historical evidence. In 2004, Chinese exports to the EU countries ' customs records are in accordance with the food capacity and not according to the registration of pharmaceuticals. Also, before the year 2000 by the Chinese customs requires only the of proprietary Chinese medicines or herbal harmonized reporting, enterprises do not have a single variety of export records.
The second is the high cost prohibitive for many enterprises. According to reports, a business of medicines if you follow the traditional plant medicine registration program instructions on registration, the registration fee of approximately 80 million RMB through EU GMP certification, production equipment, and other hardware investment required more than 400 million Yuan, and training, expert guidance, and other software investment also needed 400 million.
Nevertheless, some Chinese enterprises are still actively working towards in the 7-year transitional period ended in the EU will succeed in its product registration. It is learnt that the Sichuan Chengdu xinxuekang capsule has passed the examination of Drug Administration Department of the Netherlands, xinxuekang capsule production line also has adopted the EU GMP certification, is expected to become the first to enter the international market of therapeutic proprietary varieties; Guangzhou qixing pharmaceutical group is "United Kingdom Register of traditional herbal medicinal products summary (United Kingdom) with the EU GMP certification" project; Lanzhou feci "minshan" card dangdui also received Sweden national drug authority agreed and formally accepted, pre-assessment also has passed. But in 2011 before 31 March, these three companies in which a company will take the lead in the European Union officially obtain legal status, make traditional Chinese medicine in EU legal sales for zero breakthrough, people will wait and see.
Professor Lin Kuo-ming, practicing medicine in Europe have been getting about 20 years. He said: "in the face of such grim prospects, it is imperative that work together to respond to challenges. ”
First of all is in EU of traditional Chinese medicine practitioners should unite mutual exclusion had pulled out again. Secondly, European practitioners and patients should be joint signature requirements for the legal status of traditional Chinese medicine. Professor Lin Kuo-ming said: "in Europe, dependent on the medicine man. EU Member States is a democratic country, politicians are very important people. 2011 March 31, in European medicine practitioners can contact their patients, jointly petitioned the EU politicians, asked for the legal status of TCM, believe that these politicians do not ignore the voice of the people. "The third is the role of the Government of China. China is now the world's second largest economy in the world's increasing influence, rescue medicine in European destiny, the Chinese Government can play an irreplaceable role. Professor Lin Kuo-ming, the Chinese Government and the EU and its Member States for different levels of dialogue and negotiations should be made for the legal status in Europe.
Although the situation in Europe is very dangerous, but Professor Lin Kuo-Ming and not a pessimist. He said: "in the long run, I'm Chinese medicine into Europe or relatively optimistic. Because of the medicine in clinical treatment of superiority is very prominent, in Europe there is a large civil identity, there are many Western medicine cannot resolve disease only medicine can handle. I believe that sooner or later will break through the traditional EU traditional plant medicine registration procedures directive set of hurdles. ”
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