The threshold of European market is no longer high

Chinese medicine is the integration of ancient Chinese traditional culture and original science and technology, and the key to link Chinese traditional and modern, science and culture With the rapid development of China's economy and comprehensive national strength, traditional Chinese medicine has become an important field of China's foreign exchange, and the country strongly supports the going out of China of traditional Chinese medicine   China released China's one belt, one road, one belt, one road, and the other half of China Last year, China officially released the white paper on Chinese medicine, introducing the development of Chinese medicine to the world, indicating that Chinese medicine is becoming an important part of China's foreign exchange Last year, China promulgated the "one belt and one way" development plan for Chinese medicine (2016~2020) In the future, Chinese medicine will play a more indispensable role in the "one belt and one road" undertaking Europe, located on one side of the "one belt, one road", may become a breakthrough in internationalization of Chinese medicine Recently, Banlangen Granules of Xiangxue pharmaceutical have been officially approved by the UK drug and Health Products Administration (MHRA), and become a traditional Chinese medicine listed in the UK as a drug To promote the internationalization of traditional Chinese medicine, we should first open up the situation with unilateral botanical drugs Europe has a long tradition of production, use and consumption of botanical drugs So far, botanical drugs still occupy an important position in the European pharmaceutical market According to the data released by who, the global market size of botanical drugs in 2008 has reached nearly 40 billion US dollars, and the European Union accounts for 40% In 2004, the European Union issued the directive on the registration procedure of traditional botanical drugs, which unified the different management methods of European countries for botanical drugs The development of European botanical drug market has entered a new stage In the past 10 years, EU countries have approved the registration of more than 2000 varieties of botanical drugs The market scale of European botanical drugs has expanded rapidly, showing a strong growth trend China's traditional Chinese medicine is a bright pearl in the world's traditional medicine It has a long history and a solid foundation It has its own system from theory to practice, and its research scope and depth are at a level Up to now, Chinese traditional medicine still maintains a strong vitality and vitality, China is worthy of the world's plant medicine power However, due to some reasons, China's attention to and development of the European market is far from enough Up to now, only Chengdu Di'ao Xinxuekang capsule, Tianshili's Danshen capsule and Banlangen Granules of Xiangxue pharmaceutical have been approved in Europe In the face of this embarrassing situation, both China and the EU are actively making efforts In recent years, the chairman, vice chairman and members of the herbal medicine committee of the European Drug Administration (EMA) (hereinafter referred to as HMPC) have visited China for many times to answer questions for Chinese enterprises With the frequent exchanges between China and the EU and the deepening understanding of EU regulations on plant medicine, in the future, especially the application for traditional drugs based on European plant medicine monograph, will become an important channel for Chinese medicine to enter Europe and accelerate the process of Chinese medicine entering Europe The combination of "monarch, Minister and assistant envoy" is the essence of the application of traditional Chinese medicine However, in the process of going out of traditional Chinese medicine, the complex composition of the compound has also become an obstacle Up to now, only two botanical drugs have been approved by FDA in the United States, and they are all single preparations Different from the United States, compound botanical drugs are widely accepted in Europe About 38% of the traditional botanical drugs approved by the European Union are compound To enter the European market, traditional Chinese medicine can first open up the situation with single herbal medicine With the recognition of a series of single herbal medicine in Europe and the gradual improvement of market acceptance, it is possible to accept the application of traditional Chinese medicine in the future In the tide of internationalization of traditional Chinese medicine, Europe can be the key breakthrough direction for traditional Chinese medicine enterprises to go to sea European herbal medicine market, the threshold is no longer unattainable The European Union's directive on the procedure of registration of traditional botanical drugs stipulates that pharmaceutical enterprises can officially enter the European Union market through the simple registration procedure only if they can provide more than 30 years of medicinal history, including at least 15 years of use history in the European Union, which restricts the application of many enterprises However, what has been neglected in the past is that even if the drug has been used in the EU for less than 15 years, the application can also be submitted to HMPC as long as the quality, safety and efficacy of the drug meet all other requirements of simple application for registration However, the requirements of safety and application history can be supported in the form of monograph on plant medicine The safety of the raw materials for the establishment of a monograph on phytopharmaceuticals in the EU is recognized throughout the EU, and most of the history of the use of phytopharmaceuticals for the establishment of monographs has also been confirmed Therefore, by integrating the domestic and international academic resources of raw materials of Chinese herbal medicine products and promoting the establishment of European Herbal Medicine "monograph" of raw materials of Chinese herbal medicine, it can help reduce the requirements of drug experimental research and shorten the time of registration, improve the success rate of registration, and may be a "stepping stone" for Chinese herbal medicine to open the door of EU More than ten years ago, domestic pharmaceutical enterprises had great differences in pharmaceutical manufacturing process, production conditions and foreign requirements When applying for European botanical drug registration, a large amount of funds and time were needed to invest in technical transformation to meet the requirements of the other side, and the willingness of Chinese medicine enterprises to participate in the application was not high In recent years, with the rapid development of Chinese medicine pharmaceutical industry, many Chinese medicine pharmaceutical enterprises have carried out multiple rounds of production technology upgrading It is no longer as remote as it used to be to meet the requirements of relevant European production technologies According to incomplete statistics, there are nearly 50 enterprises that have passed the drug preparation certification in Europe, the United States and Japan For large and medium-sized Chinese medicine pharmaceutical enterprises in China, the marginal cost of production requirements for EU registration is not high, and this marginal cost will be continuously diluted in the process of continuous improvement of domestic drug quality system requirements On the other hand, with more and more foreign exchanges among Chinese pharmaceutical enterprises, pharmaceutical enterprises allocate and integrate resources in the international market through overseas factory building, establishment of branch companies and R & D institutions, authorization and transfer, international M & A, and participate in international market competition in multiple aspects Therefore, actively participating in foreign exchange will effectively reduce relevant policies and market barriers Opening up the European market will promote the sales of domestic products After the successful registration of drugs overseas, there will be a series of problems in the development of local market Due to the large difference in the operation mode of drug market between China and European and American countries in the past, a large amount of capital and other investment are needed to develop the European market, and such investment is difficult to form a substantial support for the domestic market In recent years, with the deepening of China's medical reform and the general trend of drug value return, the domestic drug sales mode is undergoing major changes The clinical value and scientific value of drugs are becoming the key to market competition The differences between the operation modes of domestic and foreign drug markets have been significantly reduced Many work needed to develop the market of products in Europe can obtain corresponding support from the domestic market Once the products are recognized in Europe, the situation will be opened, and the domestic market sales will be further promoted Which enterprises / products are suitable for going to sea in Europe? Large and medium-sized pharmaceutical enterprises of traditional Chinese medicine have a high level of quality control and technology research and development They have certain strength in market, capital, financial management and foreign exchange, and have more conditions to impact the European market In terms of products, we should start with unilateral drugs based on modern science and technology, adhere to the principle of "easy first, then difficult", start with unilateral drugs, step by step Because the European Union defines plant medicine as an over-the-counter drug for patients' self-treatment, it is generally used for mild abnormal and self-healing symptoms without medical advice Therefore, oral, external and mucosal dosage forms should be used, which are safe and easy to accept In terms of indications, EU has made it clear that products registered according to traditional herbal medicines cannot be used for treatment of critical diseases, including cancer, cardiovascular diseases and infectious diseases, so the above treatment areas must be avoided It is worth looking forward to the breakthrough of traditional Chinese medicine in the European market! Original title: Chinese medicine goes out to sea, opens up the European market at the right time author: Li Geng editor: Yuanzhi seizes the business opportunity of pharmaceutical machinery and equipment industry, please download app (Pharma, Android version)!