The development of Chinese medicine has been promoted to the national level since the 18th national congress of medicine on July 27. "Outline of national innovation driven development strategy the" healthy China 2030 "planning outline" and "strategic plan for development of Chinese medicine (2016-2030) and other documents, all focus on science and technology innovation as a development of traditional Chinese medicine, to strengthen scientific and technological innovation of Chinese medicine put forward clear request.
Recently issued by the "" much starker choices-and graver consequences-in" special planning of scientific and technological innovation of Chinese medicine ", put forward to speed up the inheritance and innovation of TCM, realize the revitalization of the development of Chinese medicine, and put forward "improve the international standard of traditional Chinese medicine, the formation of not less than 50 100 pharmacopoeia standards and industry standards, implementation of 20 ~ 30 varieties of proprietary Chinese medicine drugs registration and 5 ~ 10 varieties of proprietary Chinese medicine drug registration in Europe and the United States; to strengthen international cooperation in the research of traditional Chinese medicine" strategic objectives, such as for product internationalization of Chinese medicine to create a good time, geographical and human conditions.
Industrial output rose sharply
With science and technology innovation as the leading, modern traditional Chinese medicine (TCM) industry booming development, traditional Chinese medicine (TCM) gross value of industrial output increased from 23.4 billion yuan in 1996 to 786.7 billion yuan in 2015, the proportion of the total output value of pharmaceutical industry increased from 1/5 to 1/3, products and services of traditional Chinese medicine to speed up towards the world.
According to the WHO statistics, TCM has been recognized in 29 countries and regions, including Australia, Canada, Austria, Singapore and Vietnam. 18 countries and regions will include traditional Chinese medicine in health insurance; Chinese medicine has been registered in Russia, Singapore, Cuba, Vietnam and other countries, and has actively applied for international high-end certification for a group of Chinese traditional Chinese medicine enterprises represented by shenwei, lanzhou Buddha, and diao group. At present our country four kinds of traditional Chinese medicine (TCM) for FDA approval to carry out the Ⅲ clinical research, a number of varieties of traditional Chinese medicine has been included in the journal of the American pharmacopoeia and the European pharmacopoeia.
Pharmaceutical companies global
With the internationalization of traditional Chinese medicine, Chinese traditional Chinese medicine has mushroomed. In March 2012, the "underground heart and health capsule" of the underground group was approved and registered by the Dutch pharmaceutical audit bureau. In 2016, the modern Chinese medicine danshen capsule obtained the approval of the European Union plant medicine and successfully entered the European market.
At the same time, some of the internationalized traditional Chinese medicine enterprises have started to establish the global marketing network through investment and acquisition. In 2013, tianshili invested 1.82 million euro to acquire the Dutch shenzhou medical center co., LTD., which is subordinate to the Netherlands haidebao management co., LTD., and established the Netherlands shenzhou tianshili pharmaceutical group co., LTD. In September 2016, yiling health city technology co., LTD., a subsidiary of lingling pharmaceutical co., LTD., reached a strategic cooperation with Israel HealthWatch, making a contribution of us $15 million to become its largest shareholder.
Conclusion the < < <
Traditional Chinese medicine has gradually been connected with the world. However, the road of TCM internationalization is long and arduous. On the one hand, national laws and regulations and cultural differences have become one of the main obstacles to the development of traditional Chinese medicine. For example, the U.S. food and drug administration generally does not recognize natural plant medicines including traditional Chinese medicine. Therefore, although there are some herbal medicines in the United States, most herbal medicines are still sold as dietary supplements. On the other hand, the lack of international professional talents of high-level Chinese medicine and the uneven development of TCM education have affected the international development of traditional Chinese medicine to some extent.
Internationalization of Chinese medicine is not simply defined as in a foreign country or regional scattered, local, randomly to carry out a number of specific products trade of traditional Chinese medicine, health services and other exchanges and cooperation, but should be in the country and industry departments, under the guidance of sustainable abroad to promote Chinese medicine medical treatment, health care, industrial development, enable the international community to meet, the application of traditional Chinese medicine, promote the foreign gradually establish the doctor of traditional Chinese medicine health service system. Meanwhile, education of traditional Chinese medicine is incorporated into the national education legal system in China, providing a carrier for the overseas survival of Chinese civilization. Therefore, in the current study has been involved in the successful experience of enterprise in the world, should closely cooperate with the national "area" development strategy, to build international communication platform of traditional Chinese medicine, internationalization of Chinese medicine talents team, training in the world of traditional Chinese medicine health system in the voice.
Extends < < <
A Chinese traditional medicine company
tasly
Tianshili holding group is one of the representatives of Chinese traditional Chinese medicine. It has been exploring the international road for more than 20 years and has made a lot of efforts to explore the international market.
(1) exploring the European market, the traditional Chinese medicine danshen capsule has been successfully obtained from the Netherlands;
(2) invest in kangping medical care in Australia and build the first comprehensive medical service center with the largest scale of medical services in Sydney;
(3) founded the South African South African company in 2002 to promote the development of traditional Chinese medicine in Africa;
(4) strengthen the overseas mergers and acquisitions, investment of 1.82 million euro 2013 subscribe the Dutch centre for China pharmaceutical co., LTD., founded in the Netherlands the shenzhou tasly pharmaceutical group co., LTD., a field of overseas mergers and acquisitions of Chinese medicine first;
(5) under the strong support of the state administration of traditional Chinese medicine, the Chinese medicine world alliance, which comprises 18 well-known enterprises and institutions, has been launched into the international market in a way that is integrated by the alliance. Currently, nine projects of seven enterprises have provided international development services.
In 1996 started the compound danshen dropping pill FDA clinical declaration, after from the hardships of groping, stick to innovation, has made a major breakthrough in the internationalization of Chinese traditional medicine, its internationalization development process are shown in table 1 and table 2.
li
Zhejiang kanglett pharmaceutical co., LTD., founded in 1995, is a high-tech pharmaceutical enterprise integrating production and scientific research. The company owns kanglete injection, kanglett soft capsule, gingko leaf soft capsule, health products and fat milk injection. At present, li injection has been successfully completed Ⅱ stage of clinical trials in the United States, American FDA approval, officially entered the Ⅲ phase of clinical trial, became the first in the United States into Ⅲ period clinical traditional Chinese medicine injection (see figure 1).
Peking University
Beijing Peking University viction biological technology co., LTD. Is a company dedicated to the natural medicines and modern traditional Chinese medicine research, development, production and sales of national high and new technology enterprise, its research and development: the capsule has been done to the FDA to submit application for IND.
lingling
Shijiazhuang ridge pharmaceutical industry to promote Chinese medicine international, multiple products with independent intellectual property rights of traditional Chinese medicine has entered the international market, such as tongxinluo capsule, even take antipyretic capsule, "shensong yangxin capsule", stilbene Li strong heart capsule, ideas are varieties of product capsule has been in South Korea, Vietnam, Russia, Canada, Singapore, Indonesia and other countries registered and sales, tongxinluo capsule into the Vietnam national health insurance directory, is the first variety overseas medical insurance directory.
At present, lingling is actively opening up the European and American markets. Among them, even take antipyretic capsule in March 2016, approved by the direct Ⅱ period clinical study in the United States, this is the first to enter the United States FDA clinical research of traditional Chinese medicine in the treatment of influenza, also is the world's first to enter the United States FDA clinical research of compound Chinese medicine. In September 2016, and even take antipyretic capsule American Ⅱ formally in clinical research in Virginia. (author's unit: dongguan jinan university research institute international drug registration platform) |
