| 摘要: | 中醫藥是中華民族優秀的傳統文化，獨具使用上的特色和優勢。近年來，世界各國已經開始認可中醫藥的治療和保健作用，中醫藥在國際的地位逐漸提升，中醫藥相關產品貿易額呈逐年遞增趨勢，不僅貿易總量提高，在交易上也可以看到中藥產品正在進行結構優化的趨勢。隨著國際草藥市場的競爭越來越激烈，市場的逐漸擴大為中醫藥行業走向國際化帶來了難得的機遇，但經爭也伴隨著挑戰。而歐洲人運用植物藥有幾百年歷史，本身有著使用草藥的悠久傳統，民眾對植物藥的認識和接受度較高，以及越來越重視保健、崇尚天然這種醫療概念的普及，這些因素的總體作用下，已經使歐洲躍升為世界上最大的植物藥市場。作為全球最大的中草藥市場，並且以顯著的速度增長，歐盟自然成為中藥產品進軍國際市場的重要目標。
通過對歐盟植物藥市場及管理現狀的研究，本文嘗試對中醫藥國際化的現狀作出分析，並就歐洲市場的趨勢加以剖析提出對策，特別是針對2004年開始進行一系列為草藥樹立一系列合法化、標準化的規範，對中草藥西進歐洲產生巨大的衝擊，看似障礙，其實更像是踏進殿堂大門逐步遞升的階梯，循序而上終能叩開市場的大門。本文即是對這一系列規範的架構予以釐清作一分析表述。在文章的結構層遞上，本文首先介紹中藥國際化的概念與意義，次就中藥出口的世界態勢及歐盟市場做出現狀分析。
然而，歐盟近年來加強了對歐盟境內傳統植物藥的管理，頒佈了一系列的指令，一方面，歐盟的藥品註冊指令承認傳統植物藥可註冊為藥品，並提供了簡化程式；另一方面，申請簡化註冊本身卻也充滿了難度，如資金、使用年限證明資料缺乏和貿易壁壘等，中藥企業如果應對不利，得不到傳統植物藥品的身份，將會面臨被迫退出歐盟市場的危機。因此，中藥企業如何應對歐盟的植物藥立法帶來的機遇和挑戰，成功突破歐盟的技術標準貿易壁壘，以藥品身份進入歐盟市場，將是中藥企業面臨的嚴峻挑戰和亟待解決的問題。故本文再從歐盟中藥註冊准入制度的註冊範圍、註冊程式、註冊品質標準等方面，對所存在的障礙加以剖析，藉由分析註冊制度的層次架構，找出中草藥想要合法進入歐盟銷售的途徑，以及一旦面臨註冊障礙時，另外可能作為突破口的銷售形式。
根據歐盟現行法規，目前中藥進入歐盟市場的突破口，可以食品補充劑、藥品、化妝品和醫療器械的產品形式進入歐盟市場，通過對這些產品的主要上市途徑以及相關歐盟法規進行簡要解析，可以找出中藥產品在歐盟上市的可行途徑，並圍繞中成藥如何以這些形式進入歐盟市場展開論述，包括歐盟頒布的傳統草藥註冊指令之外，另有歐洲藥典作為合法依據的介紹等，期望為有志開拓歐盟市場的中藥企業提供一定一些思路和參考，並給出一些對策建議，以期擴大中藥在歐盟國家的市場份額。
最後，本文另從未來趨勢切入觀察，比如2019年開始在全球蔓延的新冠疫情對全世界醫藥體系帶來的衝擊，以及重新審視中醫藥功效的新思維可能重新建構中醫藥擴大市場的契機，在這種整體醫療觀念重新建構的氛圍下進行探討，也更能找出中藥在歐盟表現突圍的關鍵所在，並對這些根源進行分析，找到突破點，相信這樣也更能對中藥以藥品身份進入歐盟市場的戰略方向提供對策和行銷建議。;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. |
