Technical problems of export of traditional Chinese medicine need to be solved

So far, 40 botanical drugs from 10 countries have been successfully registered in China, but none of them have been officially registered overseas "In recent years, the export of traditional Chinese medicine is subject to many restrictions of the international pharmaceutical market, and the development is slow, especially due to the technical barriers to trade." Tan Shengcai, Deputy Secretary General of China Chamber of Commerce for the import and export of medical and health care products (hereinafter referred to as the medical insurance chamber), told reporters In order to help Chinese traditional medicine health care enterprises to better explore the international market for reference, the Ministry of commerce is planning to launch the "quality and quantity safety manual for export health care" at this autumn fair, which provides technical regulations, registration and application provisions for export markets, quality and safety projects and testing standards, and quality management system standards for production enterprises To improve the quality of health care products exported to China and to put forward specific measures and suggestions to deal with technical barriers to trade Technical regulations: the most direct impact is on the international community The demand for natural drugs, including traditional Chinese medicine, is increasing day by day The share of natural drugs in the world drug market has reached more than 30% The demand for traditional Chinese medicine in the international market is also expanding rapidly, with a growth rate far higher than that of chemical drugs According to a statistical data from who, there are about 4 billion people using Chinese herbal medicine around the world, which has great potential for internationalization In the emerging industry of Chinese traditional medicine health care, many foreign enterprises have entered the Chinese market, and occupy a considerable share At present, there are more than 170 companies and 40 groups in 124 countries all over the world devoted to the research and development of Chinese herbal medicine At present, the world's pharmaceutical companies are extending their tentacles to China 40 botanical drugs from 10 countries have been successfully registered in China, but none of them have been officially registered overseas in China In recent years, the import and export trade of health care products of traditional Chinese medicine has maintained a rapid development trend According to the statistics of customs, the total import and export volume of Chinese medicine health care products reached US $1 billion in 2005, and exceeded US $1 billion in 2006, with an annual growth rate of more than 10% By 2008, the export volume of Chinese medicine had exceeded US $1.3 billion In the past two years, facing the huge impact of the financial crisis, the export of traditional Chinese medicine products can still increase steadily In 2009, China's export of traditional Chinese medicine reached a record US $2.3 billion, of which 62% was extracted from traditional Chinese medicine The export of traditional Chinese medicine preparations and pieces of Chinese medicine has also increased significantly According to the data of medical insurance chamber of Commerce, in the first quarter of this year, the export of traditional Chinese medicine reached 693 million US dollars, an increase of 40.32% year on year Among them, Chinese herbal medicines and pieces reached US $163 million, a year-on-year increase of 44.35%; plant extracts reached US $441 million, a year-on-year increase of 44.29%; health products reached US $35.1571 million, a year-on-year increase of 19.07%; proprietary Chinese medicine reached US $54.3362 million, a year-on-year increase of 17.74% It is reported that the export of health care products in China is still dominated by the export of health care products of traditional Chinese medicine However, for traditional herbal products, there are different regulations on the administration of herbal medicine in different countries, and there are different definitions for the source of raw materials, semi-finished products / products / drugs, production and quality control However, many barriers such as laws and regulations, multi-type certification system, green standards, packaging and labeling rules, quality control and impurity detection in the registration process of pharmaceutical markets in various countries have put forward restrictions on the export of China's health products Under such strict laws and regulations, it is difficult for traditional Chinese Medicine to enter the European and American markets formally as a drug Therefore, the unified management regulations have become The future vision of Chinese medicine health products business "For a long time, European and American countries have more requirements for Chinese medicine entering the domestic market based on the standards of Western medicine, and strict requirements for registration assessment laws and regulations, which makes it very difficult for Chinese medicine health products to be registered and listed in Europe and America as drugs." Talking about Shengcai, he told reporters that health food is generally regulated and required according to food standards in Europe and the United States, so there is no need to register before listing For the Chinese medicine that wants to land in the European and American market as a drug, strict registration laws and regulations have been a full manifestation of policy barriers Breaking down barriers: as a major category of Chinese medicine export, the promotion of technical standards of health care products, with the development of health food industry, its industry legislation and regulatory management has been paid more and more attention by all countries More than 70 countries and regions in the world have made or are making regulations on the management of "health food" as a category of food, which is managed through legislation Liu Zhanglin, vice president of the chamber of Commerce for medical insurance, introduced to reporters that at present, many countries such as Australia and Canada are accelerating the legislation of traditional Chinese medicine China has also signed cooperation agreements with more than 70 countries and governments abroad to promote the legal application of traditional Chinese medicine among foreign people In recent years, the European Union, the United States and Canada have introduced relevant policies In 2004, the European Union issued the "traditional herbal medicine registration directive", which implements the registration management of traditional medicine with a certain service life and good classification In 1994, the U.S passed the food supplement health and education law, which solved the legal positioning problem of Chinese patent medicine exported to the U Administration Who is a world organization actively promoting the development of traditional Chinese medicine, and launched two volumes of Monographs on single herbal medicine in 2001 and 2002 However, at present, Chinese herbal medicine is still sold in the United States as a natural health food, tea or dietary supplement The FDA's regulations on natural botanical drugs, including Chinese herbal medicines, are still sold on the market as food or healthy food, and cannot be called "drugs" in the label, and it is prohibited to indicate or imply that certain diseases can be treated or prevented Traditional Chinese medicine products still fail to obtain legal status in the United States The official does not recognize that traditional Chinese medicine is a legal drug, so it is not managed as a drug It is generally defined as a dietary supplement, which can be sold in Chinese pharmacies, food stores and grocery stores The reporter learned that at present, China's annual demand for traditional Chinese medicine materials is about 700000 tons, of which 300000 tons are exported Japan, South Korea and other countries adopt our traditional prescriptions and process them into so-called "Chinese medicines" 80% of the raw materials of Chinese herbal medicines are imported from China At the same time, as the world's largest botanical drug market, there are 1272 varieties of botanical drugs circulating in the market More than 60% of European people have used botanical drugs, with an annual sales volume of about 5 billion euros, accounting for 38% of the world's market, and the annual growth rate remains at 6% - 7% Among the European countries, Germany and France have the largest market of botanical drugs, accounting for 39% and 29% of the European botanical drug market respectively, and the other major consumers of botanical drugs are Italy, Britain, Switzerland and Poland, etc According to the calculation of 180 million US dollars of Chinese traditional medicine exported to EU in 2008, the share of Chinese traditional medicine in European plant medicine market is less than 2%, and Chinese traditional medicine is not used as medicine in European market, but in the form of food supplement, which has not won legal status Although in recent years, with the gradual legalization of acupuncture in Europe, the market of traditional Chinese medicine in the UK and the Netherlands has shown a positive momentum of expansion, the market of traditional Chinese medicine in other European countries has not seen much improvement, and the legal status of traditional Chinese medicine in the EU still has a long way to go "The usual technical regulations are mandatory and have the most direct and extensive impact on trade, as well as the access of products to the country's market." Talking about Shengcai told reporters that Chinese traditional medicine health care products business enterprises need to improve their understanding of policy and technical barriers to trade While improving their own commodity quality and standards, they should also keep pace with the times to understand the technical regulations, export market registration and application provisions, quality and safety projects and testing standards of the main export countries or regions of our health care products, and the quality control of production enterprises This is also the original intention of the Ministry of Commerce to launch the quality and quantity safety manual of export health care.