After 7 years of transition period，According to the EU Traditional Medicine Law released on March 31, 2004 (2004-24-EC instructions，The following abbreviation instructions)，Starting from May next year，All plant medicines sold in the EU market must be registered in accordance with the new regulations，It can only be sold after obtaining a listing permit。But as of now，None of the Chinese medicine products in my country have been registered through the European Union。
To this，Liu Zhanglin, vice chairman of the Import and Export Chamber of Commerce of China Medical and Health Products, said on December 7，EU registration has entered the countdown，At present, the Medical Insurance Chamber of Commerce is in conjunction with relevant enterprises to make the last effort，In the end, 10 varieties of 4 to 5 companies entered the EU market through registration。
Enterprise: Registration of cold to the European Union
Europe is one of the main markets for Chinese medicine exports in my country，January to October this year，The number of Chinese medicine exports in my country is 937 tons，The amount is US $ 12.033 million，Among them, the EU market is 801 My stake betting apptons，stake online sports bettingExport amount is 9.808 million US dollars。
It is understood，According to the relevant clauses of the EU Traditional Medicine Law，During the 7 -year transition period from May 30, 2004 to April 30, 2011，Allows that no registered plant medicines are sold in the European market as food and other foods，At the same time, you can provide a special simplified registration program for certain traditional drugs。Simplified registration procedures include: traditional drugs have been medicinal history at least 30 years before the application day，Among them, there are at least 15 years of use in the Chinese Communist Party，During approval, it can reduce clinical research and pre -clinical pharmacy test、Clinical prestigious poison science test。At the same time，The concept of 15 years can be extended to similar medicines、Similar products。Researcher Ye Zuguang, a researcher at the Chinese Academy of Chinese Medicine, believes，This simplified program brings a line of hope to the EU market as a drug that does not clear the effective ingredients as a drug。However, what is disappointing is，In the past 7 years，Domestic enterprises respond to the instruction response flat，There are very few companies that have submitted approval applications to the EU，No product has been registered today。
Liu Zhanglin said，Chinese medicine companies in my country have a flat response to the European Union. There are several main reasons: First, the registration cost is too high，Enterprises are unbearable; second, the main battlefield of Chinese medicine exports in my country is in Southeast Asia、my country's Hong Kong and Macau region, etc.，The history of exporting to the European Union is not long，European sales record is difficult to get，At the same time, the relevant domestic certification materials are also difficult to find the original documents of exports due to the reform and restructuring of the foreign trade field; the third is that the EU's management of botanical medicines is different stake sports betting appfrom my country's Chinese medicine My stake betting appsystem，It is difficult for enterprises to meet the EU's detection standards。
It is understood，EU registration only costs one million yuan for one item，plus the on -site GMP check，The total registration cost of a product is tens of millions of yuan。2009，The amount of the EU exported to the EU in my country is only 67.359 million US dollars，The amount of each exporting enterprise is very small。Input and output are not proportional to the registration enthusiasm for domestic enterprises to register very low。
Yang Hong, general manager of Xin Shang Pharmaceutical Shanghai Medicine Co., Ltd., said，Simplified approval is expected to be within reach，Standard differences are very large。Products produced by domestic enterprises in accordance with the standards of Chinese Pharmacopoeia，Many indicators do not meet the EU requirements。At present, the European Union also has a list of illegal Chinese medicines，Directory from the endangered plant protected by the International Convention，Among them, 25 plants are listed as endangered and protected plants，Although some plants have realized home species in China，But related traditional Chinese medicine products cannot be exported。Individual varieties due to the same name phenomenon of plants in various countries，Abusing in use and cause adverse reactions，thus has a negative impact on Chinese medicine。"Although there are hundreds of medicinal plants in Chinese medicine，But like woody、Ginseng、Cistanche、Shi Ji、Western ginseng is banned by the European Union，These banned plants have a small impact on the export of Chinese medicine。”
Facts，Because the EU has differences in the management of botanical medicine and the standard system of traditional Chinese medicine，From 2007，my country ’s export volume of Chinese medicines in China has slowed down year -on -year，This year，With the gradual increase of the international market demand，my country has recovered growth in the export of Chinese medicines stake betting appin the European Union，but did My stake betting appnot change Chinese medicine products with food、The status of the EU in the name of the dietary supplement。
Chamber of Commerce: Strive for breakthroughs
No doubt，The simplified approval during the transition period of the EU instructions is an opportunity for Chinese medicine products in my country，But how to overcome a series of difficulties in registration has become a question that the entire industry and relevant government departments are concerned。
The reporter learned，In the past 6 years，Department of Commerce、Department of Technology、The responsible comrades of the State Food and Drug Administration and other relevant departments and Tongrentang、Daren Tang、China Medical and Health Products Import and Export Company、Shanghai Pharmaceutical Group and other well -known enterprises for production and exports，Top Chinese medicine experts at home and abroad held many seminars，Discuss countermeasures，Communicate with the European Union，I hope to extend the transition period to 2019，But now it seems that the hope is slim。
Professor Luo Guoan of the Institute of Drug Research of Tsinghua University has also proposed the idea of through the "curve to save the country" in Hong Kong，That is, Chinese patent medicines are influenced by the EU through Hong Kong registration。He said，Facts，EU very much hopes that Chinese medicine in China will be registered，They have no experience in how to supervise Chinese medicine。Due to the history of Hong Kong，It is closer to the UK in the concept and behavior method，Easy communication，From the perspective of Europe，Britain has always been at the leader in traditional drug legislation。
Liu Zhanglin said，Although there is no Chinese medicine in my country, there are currently registered Chinese medicine species through the EU，But there is no hope。In recent years，With my country's continuous improvement of drug quality standards，Especially the 2010 version of Pharmacopoeia and the new version of GMP re -revised，Production and testing standards stake betting appare close stake sports betting appto EU standards，It has also emerged as a large number of modern Chinese medicine manufacturers that meet the EU GMP standard。"The Chamber of Commerce is ready to select 10 varieties of 4 to 5 Chinese medicine companies for key registration，There is no problem in the registered information now，Mainly on -site inspection and management ideas。”
European Chinese Medicine Chamber of Commerce Nordic Natural Therapy Association Vice Chairman Zhu Guoguang said，The EU has a lot of people engaged in the traditional Chinese medicine industry，Although there is no legal status of Chinese medicine，But it has become a trend，Many upper people have a single clock for Chinese medicine。So，EU also hopes to incorporate Chinese medicine into legal fields，The key is the communication between the two parties，To gain trust and understanding。
