Chinese Patent Medicine EU Registration Analysis And Variety Selection Research

Traditional Chinese Medicine(hereafter TCM)is one of the traditional treasure of our country,and plays an important role in the history for thousands of years.In recent years,our country has placed greater emphasis on the development of the Chinese medicine industry,and has accelerating its internationalization process with a more open attitude.Chinese medicine has spread to 183 countries and regions.In addition,TCM has gradually entered the international medical system and has been registered as medicines,dietary supplements,functional foods and other forms in various countries.However,it still faces many problems in the process of internationalization,which reflected most in the export trade of TCM products.Objectives:Through the analysis of the international trade of TCM products between 2009 and 2016,this paper reviews and analyzes Chinese import and export trade of traditional Chinese medicine products systematically,including the distribution of import and export of traditional Chinese medicine products market,the product mix,and the distribution of main exports types and so on.An in-depth study of the potential international competitiveness of traditional Chinese medicine products has been made.The necessity for Chinese patent medicine 's registration in the EU has undergone a thorough review.Through the analysis of the registered EU traditional herbal products,we are attempting to find out the potential varieties of proprietary Chinese medicines that have the potential to be successfully registered in the EU from existing Big Brand Traditional Chinese Medicines in order so as to promote more Chinese-made pharmaceutical products into the international market.Methods:Literature analysis method,comparative analysis method and statistical analysis method are used in this paper.Through the analysis of the international trade of TCM products from 2009 to 2016,we are aiming to find out the problems faced by its exporting to the world,and find out the breakthroughs in its internationalization process.Comparing the product types registered in the EU,the registered routes,the compound formulation numbers,the therapeutic field,and the registered country of Chinese patent medicine,this paper is aiming to screen out more suitable Chinese patent medicine for registration in the EU from the Big Brand Traditional Chinese Medicines.Results:In the global trade of the TCM products,Chinese crude drugs and prepared drug in pieces,extracts are the main export products.The export volume of Chinese patent medicines is relatively small and shows a downward trend obviously.In terms of China-EU export trade,the export of Chinese patent medicines is not optimistic,especially after 2011,it's even harder for Chinese patent medicines to export in the EU.The main cause is that the EU has strengthened the supervision on herbal products,and unregistered herbal products are not allowed to use as pharmaceuticals.The number Chinese patent medicines registered in EU is rather few.By analyzing the registration of EU herbal products,it was found that the Netherlands,the United Kingdom,German and France are more suitable as the countries for the first registration of Chinese patent medicine products.Some of these countries are powers that import large quantities of traditional Chinese medicine products.Some of the countries have a higher degree of acceptance of Chinese patent medicines in which Chinese patent medicines has registered.In terms of types,try to choose unilateral preparations or compound preparations with a small number of formulation as much as possible.The Community Herbal Monograph has an important influence on the registration of traditional herbal products,and the vast majority of herbal medicines products registered with a highest frequency have established a Community Herbal Monograph.Conclusions:By the analysis of the international trade situation of Chinese medicine products and the registration of EU herbal products,the suggestions for the registration of Chinese patent medicines in the EU are as follows:to strengthen the development and basic research of the Unilateral Chinese patent medicine single Chinese patent medicine and the potential compound Chinese patent medicine;to actively carry out exchanges with the European Union in various aspects and to promote the establishment of more Community Herbal Monographs about TCM.What's more,we should strengthen targeted research on the international market,promote the spread of TCM culture and cultivate localized talents.