| 摘要(英) |
Traditional Chinese medicine is an excellent traditional culture of the Chinese nation, with unique characteristics and advantages in use. In recent years, countries all over the world have begun to recognize the therapeutic and health care functions of traditional Chinese medicine. The international status of traditional Chinese medicine has been gradually improved. The trade volume of TCM related products has been increasing year by year. Not only the total trade volume has increased, but also the trend of structural optimization of TCM products can be seen in the trade. With the increasingly fierce competition in the international herbal medicine market, the gradual expansion of the market has brought rare opportunities for the internationalization of traditional Chinese medicine industry, but the competition is also accompanied by challenges. The European use of herbal medicine has a history of hundreds of years, and has a long tradition of using herbal medicine. People have a high degree of understanding and acceptance of herbal medicine, and pay more and more attention to health care and advocate the popularity of natural medical concept. Under the overall effect of these factors, Europe has become the largest market of herbal medicine in the world. As the largest Chinese herbal medicine market in the world, and with a significant growth rate, the EU naturally becomes an important target for Chinese herbal medicine products to enter the international market.
Through the research on the current situation of EU botanical medicine market and management, this paper attempts to analyze the current situation of internationalization of traditional Chinese medicine, and puts forward countermeasures on the trend of European market. In particular, since 2004, a series of legalized and standardized norms have been established for herbal medicine, which has a huge impact on the Western entry of Chinese herbal medicine into Europe. It seems to be an obstacle, but in fact, it is more like stepping on it Step by step, step by step, you can finally knock on the door of the market. This paper is to clarify the structure of this series of norms and make an analysis. In the structure layer of the article, this paper first introduces the concept and significance of the internationalization of traditional Chinese medicine, and then analyzes the world situation of the export of traditional Chinese medicine and the emergence of the EU market.
However, in recent years, the EU has strengthened the management of traditional botanical drugs in the EU, and issued a series of directives. On the one hand, the EU′s pharmaceutical registration directive recognizes that traditional botanical drugs can be registered as drugs, and provides simplified procedures; on the other hand, the application for simplified registration itself is also full of difficulties, such as lack of funds, proof of service life and trade barriers, etc If we can not get the identity of traditional plant medicine, we will be forced to withdraw from the EU market. Therefore, how to deal with the opportunities and challenges brought by EU′s plant medicine legislation, how to successfully break through EU′s technical standard trade barriers, and how to enter the EU market as a drug will be a serious challenge and an urgent problem for Chinese medicine enterprises. Therefore, this paper analyzes the existing obstacles from the aspects of registration scope, registration procedure and registration quality standard of EU registration and access system of traditional Chinese medicine. By analyzing the hierarchical structure of registration system, it finds out the way for Chinese herbal medicine to enter the EU legally, as well as the sales form that may be a breakthrough once faced with registration obstacles.
According to the current EU regulations, the breakthrough point for Chinese medicine to enter the EU market is that it can enter the EU market in the form of food supplements, drugs, cosmetics and medical devices. Through a brief analysis of the main marketing channels of these products and relevant EU regulations, we can find out the feasible ways for Chinese medicine to be listed in the EU, and focus on how to use these forms of Chinese patent medicine It is expected to provide some ideas and references for Chinese medicine enterprises who are interested in exploring the EU market, and give some countermeasures and suggestions to expand the market share of Chinese medicine in EU countries.
Finally, this paper also observes from the perspective of future trends, such as the impact of the global spread of the new crown epidemic in 2019 on the world′s pharmaceutical system, as well as the opportunity for the new thinking of re examining the efficacy of traditional Chinese medicine to re construct the market expansion of traditional Chinese medicine. In this atmosphere of re constructing the overall medical concept, it is also more able to find out the breakthrough of traditional Chinese medicine in the EU The key is to analyze these causes and find a breakthrough point, which is believed to provide more countermeasures and marketing suggestions for the strategic direction of traditional Chinese medicine entering the EU market as a drug. |
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