Drugs at the forefront of internationalization of traditional Chinese Medicine

Chinese medicine is the treasure of the Chinese nation, reflecting the great wisdom of the Chinese nation Internationalization of traditional Chinese medicine is the way to show China to the world, and it will play an indispensable role in promoting the modernization of traditional Chinese medicine As early as 1998, China has formulated the action plan for the modernization of science and technology industry of traditional Chinese medicine, which puts forward the goal of internationalization of traditional Chinese medicine The outline of strategic planning for the development of traditional Chinese medicine recently issued also shows the encouragement and determination of the state for the development of traditional Chinese medicine industry With the continuous deepening of the world's understanding of traditional Chinese medicine, drug regulatory agencies in various countries are gradually improving the corresponding regulatory and declaration system For example, in 2004, FDA issued the botanicaldrug products guide, which was revised in 2015, and released the botanicaldrug development (draft guidance) 1、 There are two FDA approved botanicals The first is that on October 30, 2006, the FDA approved green tea extract veregen for the treatment of genital and perianal condyloma acuminatum in patients aged 18 years and over with immune impairment, which belongs to external medicine It was not until December 31, 2012 that the FDA approved the second botanical drug, fulyzaq, a Croton extract, for the treatment of AIDS related diarrhea, the first oral botanical drug approved by the FDA These two approved drugs show that FDA's understanding of the safety and efficacy of botanical drugs is gradually improving At the same time, it should be noted that the administration of these two drugs is relatively safe for external use and oral preparations, and the components are relatively simple Two, the characteristics of botanical drugs in the IND declaration stage in addition to the drugs approved for marketing, there are many botanical drugs in the IND research stage It is reported that dozens of Chinese medicine products have submitted their ind applications to the US FDA The following table lists some clinical trials in phase II or phase III There are some common points of the above drugs in the forefront of internationalization of traditional Chinese medicine: ① they are products that have been on the market for many years in China, mostly large varieties of traditional Chinese medicine Clinical application experience is rich, safety and effectiveness have been fully verified, adverse reaction information is more comprehensive Therefore, it is possible to obtain FDA approval for clinical trials ② Abundant literature supporting materials, including preclinical and clinical research literature, provide more supporting data for clinical approval For example, CNKI can search nearly 20000 articles related to compound Danshen dropping pills and more than 3000 articles related to Guizhi Fuling Capsule ③ In addition to the newly approved phase II clinical Lianhua Qingwen capsule of 15 years as 13 large compound prescriptions, other drugs are relatively simple and composed of 1-6 herbs, and the challenge in providing CMC data in line with regulatory requirements is relatively small ④ In addition to Kanglaite injection, the rest are oral dosage forms Kanglaite injection only contains a single herbal extract, and its components are relatively simple, so it is easier to achieve good drug quality control 4、 Enterprise strategy of internationalization of traditional Chinese medicine 1 How to choose indications? In order to declare ind to FDA, we need to select indications that meet the definition of disease in western medicine theory The functional indications under the guidance of traditional Chinese medicine theory are not approved by FDA temporarily So, how to choose indications? ① Select indications that do not meet clinical needs, such as indications that lack or do not have effective drug treatment methods For example, the selection of fulyzaq indications and Fuzheng Huayu tablet indications are examples ② Careful evaluation of the mechanism of action of the drug, preclinical research data and existing clinical application experience, clear indications and significant clinical benefits are key factors for approval ③ The rich incentive policies of FDA should be considered in the development process For example, policies related to orphan drug identification and funding for rare disease products; priority review, fast track, breakthrough therapy and other possible approval channels ④ The number and difficulty of subjects recruited, the cost and length of time to conduct clinical studies, and other business considerations are also factors to be considered 2 Overseas declaration of international cooperation in traditional Chinese medicine has brought a variety of international cooperation modes Such as: ① cooperation with foreign research institutions ② Cooperate with international cro with rich experience in clinical trials To seek experts' suggestions on trial design and clinical development scheme, select qualified cro to monitor GCP compliance and data management of clinical research, and ensure the writing of qualified clinical research report ③ Cooperate with overseas consultants who are familiar with overseas application regulations and technical guidelines At present, some consulting companies / cros are based at home and abroad, providing enterprises with more convenient ways of cooperation and communication, such as Fang en, Humphrey, yaang, tag, etc Conclusion: more and more Chinese patent medicines have entered the US ind, and FDA is gradually improving its regulatory and development guidelines for Chinese patent medicines These progress are enough to see that FDA's recognition of traditional Chinese medicine is gradually increasing, and the national incentive policies have been gradually established and improved It is believed that more and more excellent Chinese medicine enterprises will bravely embark on the international journey, and the selection of varieties and indications for international development is one of the first issues we need to think about when we start the international journey Forerunners will always encounter more challenges Challenges are opportunities as well as progress In the process of internationalization, the research according to the requirements of the target market is not only the only way for enterprises to obtain the approval of listing, but also a process of RE development, re innovation and re validation of listed drugs It will be a glorious undertaking.