Nowadays,Chinese medicine industry in China is flourishing,but Chinese medicine has not yet entered the international main medical market.And there is a long way for Chinese medicine’s internationalization.The United States and Europe markets are recognized as world’s regulated pharmaceutical markets,and most countries use their drug regulations as a reference to formulate corresponding laws and regulations.In addition,the US has the most stringent drug regulation in the world.If Chinese medicine can be successfully listed through US drug certification,the internationalization of Chinese medicine will be more convenient.It can be seen from the existing public information that in the mainstream pharmaceutical markets,only 3 cases of Chinese medicines such as Dioxinxuekang Capsules,Tasly Danshen Capsules and Xiangxue Banlangen Granules have been successfully listed in the EU,while the US market has not yet had FDA-registered Chinese medicine products.At present,most of the researches at home and abroad are about the development of botanical drugs or the internationalization of traditional Chinese medicine.There are few specific studies focusing on the entry of traditional Chinese medicine products into the mainstream markets in Europe and America.Therefore,this article will focus on the US market,using a combination of qualitative and quantitative methods to conduct strategic research on the access of Chinese medicine products in the US market.ObjectiveFirst,This study intend to analyze the market situation of natural health products in the US and the status quo of traditional Chinese medicine products exported to the US,getting a preliminary understanding of the current status of the US market.Second,collecting literature,analyzing the registration and filing policies and experience of Chinese medicine in the US,and sort out the regulatory requirements of the US FDA.Third,analyzing US-listed botanical drugs,dietary supplements and Chinese patent medicines being applied.Finally,Finding the influence factor of Chinese medicine listing in the US and understanding the opportunities and challenges of TCM products listed in the US with SWOT analysis,making recommendations through qualitative and quantitative analysis,.This study aims to promote more Chinese medicine companies and products enter the US market in various forms.Methods(1)Data analysisCollecting and analyzing customs data and US botanical product market data.Making a primary understanding of the export situation of Chinese medicine products and the market situation of US botanical products from the trends,product distribution,variety comparison and other aspects,(2)Literature researchBy studying CNKI,the US FDA official website,database and the professional books related to the internationalization of Chinese medicine,and the literature related to the listing of Chinese medicine in the US is searched,making a systematic review of US drug registration,dietary supplement registration and guidance documents,mapp,etc.The status of registration of Chinese medicine products and the route of Chinese patent medicines listed in the US is clarified.(3)Model researchBased on the literature research,the SWOT model of Chinese medicine marketed in the US was established,analyzing the matrix of influencing factors for the establishment of Chinese medicine in the US.(4)Empirical researchCombine the lessons and experience with two kinds of botanical drugs that have been successfully marketed in the US,two Chinese medicines applied IND,and related practices of Chinese medicine products listed as dietary supplements in the US.Based on the classical gravity model,incorporating economic,cultural and policy factors,an empirical analysis model is established,objectively analyzing the factors affecting the Chinese medicine products marketing in the US.ResultBotanical products have broad market prospects in the US,and most varieties of the best-selling plant in the US have certain health effects.The botanical products exported to the US are mainly botanical extracts,which are mostly used as raw materials or semi finished products.The Chinese herbal medicines account for a relatively low proportion,and the export structure is seriously unbalanced.At present,most of Chinese medicine products are sold in the US as dietary supplements.Their use is not regulated,and there are often cases of improper use or dialectical.It is easy to cause abuse of Chinese medicines and thus leading a negative impact on Chinese medicine products.Traditional Chinese medicine products have two standardized marketing routes in the US,one is to enter as a dietary supplement,and the other is to enter as a drug through NDA or OTC monograph.The case analysis show that enterprises should pay attention to product selection and product quality control.The two listing methods have their own advantages and disadvantages,and enterprises should properly choose the appropriate listing route.The empirical results show that China’s exports of Chinese medicine products to the US have a significant positive correlation with the US population and the American Chinese population at the 1%level,and have a negative correlation with US dollar against the CNY exchange rate at the 1%level,which mean CNY appreciation block the export of Chinese medicine products,while the expansion of the US market and the enhancement of cultural communication can promote the export of Chinese medicine products to the US.The SWOT analysis show that Chinese medicine products in the US market have the advantages of resources,production and theory,and it is supported by the Chinese government.However,it also has certain disadvantages due to the lack of international talents,the lack of internationally recognized quality standards,the dependence of traditional Chinese medicine theory,and insufficient research and development investment.The change of consumer concept,the rise of natural health industry and the toxic side effects of chemical drugs have increasingly given Chinese medicine products the opportunity to enter the US market.But Chinese medicine products are also facing trade barriers in the US market,global competition and cultural differences between China and the West.Conclusion and suggestionThrough the research on the status quo and influencing factors of traditional Chinese medicine products in the US,relevant countermeasures have been obtained:(1)In terms of products,appropriate Chinese medicine products should be launched for the needs of the US market.A good communication with the FDA should be established,choosing a reasonable reporting route for the product;Strictly controlling product quality and quality standards in line with international standards should be established.(2)As for enterprises,they should work with US research institutions to provide more convincing results from local institutions.They should take advantage of the resources,technology and the advantages of local enterprises,take the capital localization and development to enter the US market and reduce the restrictions on technical trade barriers.At the same time,we should pay attention to the protection of patents and protect the legitimate rights of enterprises themselves.(3)In terms of cultural promotion,it is possible to take the coordinated development of trade in goods and services,driving medicines sales with medical services,improving the influence of Chinese medicine products.Focus on cultivating international talents;organize,compile and translate traditional Chinese classics and issue them to the public,spreading the culture of Chinese medicine actively and accurately.Integrating the characteristics of Chinese medicine culture,spreading the charm of Chinese medicine and improving the acceptance of Chinese medicine products by American people. |