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The internationalization of traditional Chinese medicine must pass five levels
Release time: 2010-09-13 & nbsp & nbsp & nbsp Source:
     Although Chinese medicine spreads to more than 160 countries and regions in the world,But it is generally difficult to enter the mainstream international pharmaceutical market,Most of them can only be used in the Chinese circle
      ① Law Pass
Chinese medicine is just supplemented and alternative in most countries and regions
Australian patients 30 -year -old Australian patient Cesreo has been unable to get pregnant,The diagnosis of Western medicine is infertility for life。Passing through Tongrentang Sydney Branch Wu Gaoyuan TCM 6 treatment,She succeeded in getting pregnant。What makes her unexpected is,Dr. Wu told her that she was pregnant with a pulse。Cesreio went to the hospital for examination,When Western medicine notify the same result,She is so excited to tears and eyes。Now,Her family has become the supporter of Chinese medicine。
It is understood,May 2009,Australia Victoria Establish "Traditional Chinese Medicine Law (including acupuncture)",This is the world's first Chinese medicine legislation,and therefore produced the state's Chinese Medicine Supervision Administration。Australia is therefore known as "Bridge Fort in TCM to the World"。Current,my country has signed more than 90 government agreements with Chinese medicine cooperation with more than 70 countries (regions) in the world。
Due to lack of legal status,In some countries,Chinese medicine cannot do medicine,Chinese medicine cannot be sold public,The use of Chinese medicine cannot enter medical insurance。Some people in the industry said,Not included in the medical insurance system,is another big bottleneck that restricts its internationalization。
Chinese medicine can survive in the world in three categories: First, integration。In China、Korea、Vietnam and other countries,Traditional medicine and western medicine are supported by the government,Volkswagen recognition。The second is legislation。Australia、Some provinces (states) of Germany and other countries introduced regulations,The legal status of protecting Chinese medicine and Chinese medicine。Third, let it go。It is neither legal nor illegal,For example, Greece、Sweden and other countries regulations,As long as there is no medical accident,I will not be interfered。Even in a country with legal status in Chinese medicine,Chinese medicine is also a substitute for medical treatment,Can't sit flat with Western Medicine。
Although Chinese medicine stake online sports bettinghas My stake betting appspread to more than 160 countries and regions in the world,But it is generally difficult to enter the mainstream market of international medicine,Most of them can only be used in the Chinese circle。"Chinese Medicine Internationalization" slogan has shouted for many years,Chinese medicine has been hovering at the door of the house。
Li Lianda, an academician of the Chinese Academy of Engineering: "Chinese medicine goes to international,refers to going global as a prescription medicine,instead of going out as a health food,Need to enter the mainstream medical system of the other party,But now we are still far from this requirement。”
② Funding
Through the clinical trial of the third phase of the US FDA,About 5? 8 years,Spending 500 million? 600 million US dollars,The threshold for registration of foreign medicines is getting higher and higher
Chinese medicine goes abroad,Most companies will choose to go to the US Food and Drug Administration (FDA) for drug registration。How much time does it take to register through drugs? Most companies are not clear。What is the detailed provisions of the registration of drugs? Chinese companies know less。Domestic Chinese medicine companies only rely on the courage of "newborn calves are not afraid of tigers",Is it impossible to cross the threshold for registration of Europe and the United States。
Experts point out,A new drug takes about 5 to 8 years through the three -phase clinical trial of the FDA,Spending about 500 million? 600 million US dollars。FDA has a sound and comprehensive drug review legal system,It is the "gold standard" for approval of the new drug approved by global medical institutions and consumers。Once successfully entered the US market,It also means that you can enter Europe smoothly、Japan and other important global markets。
At the end of 1997,Compound Danshen Di Pills produced by Tzuhiki Corporation officially passed the FDA clinical research approval,The first compound traditional Chinese medicine preparation that passed the approval of this approval。Due to the large gap with the requirements of the FDA,I have to strand the application for registration。Tzuhiki Group continues to improve production technology,Apply until 10 years later。Yan Xijun, chairman of Tiansi Group, admits,Fu Fang Danshen Di Pills declare FDA to the current stage,I have paid a lot of tuition fees,It can be regarded as "ten years grind a sword"。
Expert said,Drugs enter one、Phase II clinical is not particularly difficult,But once it enters the third phase of clinical clinical,Cost and difficulty will greatly increase,Risk is also greater。Statistics data show,Only about 1/15 candidate drugs can pass all the third phase clinical trials of the FDA and eventually meet consumers,Most drugs are forced to stop at the second phase of the clinical trial stage。
This threshold for registration of drugs cannot be broken,Chinese medicine exports will not have significant growth。European "Traditional Botanical Registration Procedure instructions" in 2011 is coming to,Europe's management of botanical medicines is increasingly strict。Whether it is a Chinese company or a person in the Chinese medicine industry in Europe,will face great business risks,Chinese medicine exported to Europe may be punished at any time。
Liu Zhanglin, vice chairman of the China Medical Protection Chamber of Commerce, said,After 2011,The cost of stake online sports bettingregistering traditional Chinese medicine in Europe will increase Stake Sports Betting100 times。The current cost of Chinese medicine in Europe is about 10 million yuan.,Large and medium -sized pharmaceutical companies can bear。and after 2011,Register through European drugs,It takes about 1 billion yuan。If you do not pass the simple registration before 2011,If you want to register through conventional channels in the future, add difficulty。
③ Standards
Foreign security as an excuse to set up the "Green Trade Barrier"
In some domestic medicinal materials area,Pharmaceutical farmers still use a large number of "snakeskin bags" containing "snakeskin bag" containing medicinal materials。This exogenous pollution,It will form toxic and harmful substances during the processing of traditional Chinese medicine preparations,Caused the export of Chinese medicine to encounter barriers。Current,The exports of Chinese medicine products in my country are subject to many restrictions in the international market,Among them, heavy metal、Pesticide residues and microorganisms limited。
With the upsurge of foreign drug research and development, it continues to upgrade。Some developed countries In order to protect their interests in the international herbal medicine market,Establish a variety of barriers with safety as an excuse,Continuously strengthen management measures for imported Chinese medicine,Formulate or improve technical requirements for related quality,Gallow "Green Trade Barna",Chinese medicine in my country is difficult to enter the international market,seriously hinder the process of Chinese medicine going to the world。
According to the statistics of the China Medical Insurance Import and Export Chamber of Commerce,Chinese medicine products from the rejected door of our country,60%or more is poured under the green barriers。Report display,2009,my country's plant -derived Chinese medicinal materials blocked 85 batches,Special diet blocked 79 batches,Animalized Chinese medicinal materials blocked 24 batches。
Compared with developed countries,my country has a heavy metal in the planting of Chinese medicine in China、The control of pesticide residues is late。Many companies have not yet mastered foreign plants about plant medicines、Pesticide residue standard data。Zhang Boli, an academician of the Chinese Academy of Engineering, believes: "In the past, many of our companies were unsuccessful,is not familiar with the international standard system,Even foreign text did not understand。” 
To participate in the international market competition,The Ministry of Commerce promulgated the "Pharmaceutical Plants and Preparation Foreign Trade Green Industry Standards",For heavy metals、Pesticide residues and cinomotin related indicators to control,and entrust the China Medical Protection Merchants to promote this standard,Guidance exporting enterprises to meet the "green Chinese medicine" standard,Green barriers across foreign abroad。
"Who mastered the right to formulate standard,Whoever has the initiative of technology and economic competition to a certain extent。"Huang Jianyin, vice chairman of the Federation of the World Chinese Medicine Association, believes,China ’s weakness in the dominant dominance of traditional Chinese medicine,It has nothing to do with the embarrassing status of Chinese medicine in the world。Main me,Formulate and promote the internationalization stake betting appstandard of Chinese medicine,Evercorcons。
Stake Sports Betting④ Cultural level
Traditional Chinese Medicine "Can't say it、Tao Unknown、Can't understand ",Must allow foreigners to have cultural identity
"Most Chinese medicine is compound,Effective ingredients are particularly many,and most western medicine ingredients are relatively single compounds。Chinese medicine formula comes from thousands of years of experience accumulation,It's hard。But the requirements of the American FDA verification must be clearly explained,Due to cultural differences,It is difficult to enter the US European market。"" Sun He Shen, vice president of Tzuice Group, who has served in the US Food and Drug Administration for many years。
Yin and Yang、Vanity,The concept of traditional Chinese medicine that these people are still difficult to say,How to make foreigners understand? Chinese medicine "can't tell、Tao Unknown、I don’t understand ",greatly affecting the international promotion of Chinese medicine。A foreign expert once asked Academician Li Lianda,Why massage the liver,Do you rub it on your stomach or pull it out?
Ding Yongling, deputy general manager of Beijing Tongrentang (Group) Co., Ltd. said: "Let foreigners who do not believe Chinese medicine take Chinese medicine、Look at traditional Chinese medicine,It must be done from cultural communication。Internationalization of Chinese medicine,legislation is the basis,Standardization is the key,Cultural identity is fundamental。”
Ding Yongling emphasized,Chinese medicine go global,should always adhere to the characteristics of Chinese cultural characteristics,Adhere to the cultural characteristics of Chinese medicine,Selling medicine,Communication culture again,It's excellent quality、Pharmaceutical sales with significant effects to overseas,also bring Chinese culture, especially Chinese medicine culture overseas。
In recent years,Tongrentang joined hands with the Confucius Institute,Vigorously promote Chinese medicine culture。Tongrentang signed an agreement with the Confucius Institute of Nanyang University of Technology in Singapore,Paid Chinese Medicine Experts at Confucius Institute to lecture,and treat Tongrentang Branch as a training demonstration base for teachers and students of the Confucius Institute,Win the trust of local residents for TCM。Ding Yongling said: "Such a small country in Singapore,We thought it would be saturated when I opened a branch,I didn’t expect to pass the publicity,Stimulated their needs for Tongrentang,4 stores in Singapore。”
⑤ Marketing
High investment and high risk does not mean high profits
Chinese medicine is successfully registered in Europe and the United States,Just the first step of the Long March。Analysis of industry insiders,After the drug is successfully registered abroad,You must go through the market test。Some Chinese medicine varieties incorporated into foreign medical insurance directory,Can't sell in local hospitals and pharmacies,Doctor cannot open,Patients cannot use。Drug registration is high investment、High risk,But it does not mean that high profits。
"The internationalization of the Chinese medicine industry in my country is still in the growth stage。"Liu Zhanglin emphasized,The concept of internationalization Stake Sports Bettingof the so -called traditional Stake Sports BettingChinese medicine industry,According to economics theory,It can be defined as "Make a certain industry or product from being controlled and protected by the world by crossing the country",Divided into product internationalization、Three levels of internationalization and industry internationalization。Product listing is just the first step of internationalization。
"Actually,Not all domestic Chinese medicines in China are suitable for applying for an international road to the United States FDA。"Yan Xijun believes,Traditional Chinese medicine products should take a diversified international road,Traditional Chinese medicine is different from modern Chinese medicine、Classification Guidance。
Tongrentang in the internationalization process,Always insist on easy first and then difficult、Cooperation before trade、Principles of Europe and the United States first and then Europe,Restrictions on different markets,A flexible and diverse export form。For example,Southeast Asian market policies are more loose,officially entered in the form of drug registration; there are many market restrictions in the United States,Enter in the form of food supplements。
Beijing Tongrentang so far in Australia、Singapore、Malaysia and other 16 countries and regions opened at least 41 unified store retail terminals。This century -old brand has sent more than 100 experienced Chinese medicine practitioners to overseas retail stores,Overseas patients who come to the store with service。Current,Tongrentang in Australia、Canadian branches are 20%、10%of customers are locals。
Nikko Qingxin Pill is one of the examples adapted to local conditions。Niuhuang Qingxin Pills have good effects,But the Ministry of Health and Ministry of Health in Japan did not issue an import license。To enter the Japanese market,Tongrentang joined forces with the Japanese water company with a history of 30 years of cooperation,The name of the new "Sunshui Qingxin Pill",Register in Japan,Tongrentang Production。This changing effect is very good,Rishui Qingxin Pills annually selling the number of export varieties in Tongrentang。