Open a prescription for Chinese medicine in the EU market

The European Commission announced in a press release on May 29 that the EU Directive on traditional botanical drugs will be fully implemented from May 1, when unregistered traditional Chinese medicine will not be allowed to be sold and used in the EU market According to EU officials, so far no case of traditional Chinese medicine has been registered Objectively speaking, the connotation of traditional Chinese medicine culture and the unique efficacy of traditional Chinese medicine are constantly recognized around the world, and the international community is increasingly accepting traditional medicine According to the data, at present, more than 70 countries have formulated laws and regulations on herbal medicine, and more than 120 countries and regions have established various types of traditional medicine institutions, which has driven the growth of demand for herbal medicine At present, in addition to the strong demand in Southeast Asia, the traditional medicine market in North America, Western Europe, Africa and the Arab region is also gradually expanding Taking "acupuncture and moxibustion of traditional Chinese medicine" as an example, it has been developed and used in the United States for more than 40 years It is increasingly accepted by Americans as the main auxiliary treatment method Many state governments have formally legislated to ensure the promotion and application of acupuncture and moxibustion of traditional Chinese medicine In November last year, the fifth meeting of the Intergovernmental Committee for the protection of intangible cultural heritage of the United Nations decided to list Chinese acupuncture and moxibustion as intangible cultural heritage of UNESCO However, this does not mean that traditional Chinese medicine, which has a long history of thousands of years of plant medicine, has occupied a certain position in the overseas market According to the data, the annual sales volume of the world herbal medicine market is about 16 billion US dollars, and the annual growth rate is 10% to 20% However, as a big country of traditional Chinese medicine, China's annual export of traditional Chinese medicine is only about US $100 million, while the import of natural plant medicine has exceeded US $600 million, and the import volume has far exceeded the export volume The annual sales of Chinese herbal medicines in the international market account for about 20% of the drug sales, most of which are products from Europe and Japan, while China only accounts for less than 10% of the global market share of herbal medicines However, none of the Chinese herbal medicines reported in the above news has been registered in the European Union and will be banned from sale and use in the European Union, which is also a reflection of this dilemma The culture of traditional Chinese medicine is indeed broad and profound, but for a long time, due to the lack of profound research on the scientific and technological content of traditional Chinese medicine and its integration with international standards, the research on inconvenient use, poor taste and slow effect of traditional Chinese medicine has not been effectively promoted, and it has not developed enough in terms of international commonly used terminology, detection methods and quality control standards, as well as the lack of management of relevant departments In recent years, there have been more and more reports of adverse reactions caused by taking Chinese medicine by mistake This not only makes Chinese people awe many Chinese medicines, but also urges the EU, the United States, South Korea and Hong Kong to issue laws and regulations to further regulate the access system of Chinese medicine, which makes Chinese medicine enterprises go abroad The wall of the door is higher and higher, and the lazy days of the primary marketing stage are gone In today's economic globalization, it's not a good thing that some Chinese medicine enterprises encounter obstacles in the EU market because of their quick success and short-term benefits and irresponsible processing of Chinese medicine products Only in this way can we constantly reflect on how to innovate the excellent traditional culture of Chinese medicine, how to use the modern Western medicine management system to improve the production and quality of Chinese medicine Management system, and then bravely accept the test of international standards, so that Chinese medicine quickly to the world At present, our related work is relatively slow As early as 2004, the EU "directive on traditional botanical drugs" has given botanical drugs including traditional Chinese medicine a 7-year transitional period to apply for registration in member countries According to incomplete statistics, there are about 350 botanical drugs successfully registered in the EU during the transitional period, but none of them have been registered This is because the EU registration conditions must have the past 15 years of EU medical history certification, plus several million yuan of registration fees and other related factors However, if the Chinese traditional medicine enterprises really make efforts, even if the "EU medical history certification in the past 15 years" conditions are not met for a while, there will be relevant drug safety numbers that the relevant EU departments can trust According to and the reasons, the EU is encouraged to adapt some traditional Chinese medicine products As for the relatively high registration fee, it is the necessary cost to open up the huge international market of the EU, which means that it is not strong enough in determination, confidence and strength It should be noted that at present, the EU is the world's largest market for botanical drugs, with annual sales of over 10 billion euros The EU countries, mainly Germany, France and the United Kingdom, imported plant extracts from China increased by more than 60% in 2010 Such a huge market is not only the extracted plants provided by our country, but also the drugs with more scientific and technological content In this regard, some Chinese medicine enterprises have tried to build a modern Chinese medicine industry chain that conforms to international standards With the help of the state's preferential policies for well-known enterprises of traditional Chinese medicine, in about ten years, Tishi group has established the first drug source base in Shangluo, Shaanxi Province, which conforms to the gap (quality management standards for the cultivation and production of traditional Chinese Medicine), as well as the GEP (quality management standards for the extraction and production of modern traditional Chinese medicine and plant medicine) and other modern pharmaceutical management systems Moreover, the group's Compound Danshen Dropping Pills completed the FDA phase II clinical trial last year, becoming the first Chinese patent medicine to enter the FDA phase III clinical trial, revising FDA officials and doctors' views on Chinese medicine, making their regulations and standards adjusted in the formulation In August last year, Margaret hamber, the US FDA director who visited China, said that at present, China has become the world's largest supplier of active pharmaceutical ingredients for pharmaceutical products and some supplements "Traditional Chinese medicine culture, we also need to learn," she added Obviously, the world pharmaceutical industry, which has a long history of traditional Chinese medicine culture, will not ignore China's excellent traditional culture under the global market pattern As the Chinese pharmaceutical industry, we should also deeply reflect on how to use this mentality to absorb the international advanced pharmaceutical concepts and technologies, improve and innovate the system and mechanism in the development of traditional Chinese medicine as soon as possible, and change the system and mechanism in the development of traditional Chinese medicine, in addition to the long-term urgent need for quick results and instant benefits The stubborn disease of mismanagement is a good medicine for Chinese medicine to go to the world as soon as possible.