What China needs is not the modernization of traditional Chinese medicine, but the modern management of traditional Chinese Medicine

On August 29, director Bi Jingquan of the State Food and Drug Administration (hereinafter referred to as CFDA) said at the founding meeting of the 11th Pharmacopoeia Committee that "to study the essential characteristics of modern medicine and traditional medicine, as well as the differences between modern medicine and traditional medicine, to study the basic concepts of modern medicine and traditional medicine, and to clearly define its connotation and extension." This speech shows that the government hopes to have new thinking and understanding on the supervision and development mode of Chinese medicine There are many definitions of modernization of traditional Chinese medicine In the book "modernization development strategy of traditional Chinese medicine" edited by Gan Shijun and nearly 100 experts, it is proposed that modernization of traditional Chinese medicine should be based on inheriting and developing the advantages and characteristics of traditional Chinese medicine, making full use of the methods and means of modern science and technology, drawing on the internationally accepted standards and norms of medicine, research and development can enter into international medicine legally To improve the competitiveness of traditional Chinese medicine in the international market Although the four modernizations have been completed in China, there is no hope for the modernization of traditional Chinese medicine for more than 20 years Western medicine is not satisfied with the gap between traditional Chinese medicine and modern medicine, lacking reliable evidence-based medicine and low degree of standardization; traditional Chinese medicine is also not satisfied, believing that the modernization of traditional Chinese medicine deviates from the theory of traditional Chinese medicine, and some experts even say that "with the modernization of traditional Chinese medicine, traditional Chinese medicine will die" The way to apply for the listing of Compound Danshen Dropping Pills by FDA is a miniature of the strategy of the realization of traditional Chinese medicine in China It has been going on for 20 years, but the future is still uncertain However, even if the compound Danshen dropping pills are approved to be listed in the United States by FDA, is the modernization of traditional Chinese medicine successful, or is it right to represent the way of the realization of traditional Chinese medicine? No! The success of Compound Danshen Dropping Pill in FDA in the United States is nothing more than the success of botanical drugs, which is a modern combination of natural drugs; just like the success of artemisinin is not the success of traditional Chinese medicine, once it becomes a monomer with a clear chemical structure, the chemical drugs will naturally bring it into their arms What's more, there are thousands of varieties of traditional Chinese medicine and tens of thousands of drug approvals in China How to modernize? Originally, western medicine and traditional Chinese medicine are not products of the same path In fact, western medicine refers to modern medicine (not drugs from western countries), while traditional Chinese Medicine refers to traditional Chinese medicine (drugs under the guidance of traditional Chinese medicine theory) Now, the way of realizing traditional Chinese medicine is to manage traditional Chinese medicine completely according to modern (NATURAL) medicine, and put a big size shoe on three inch Golden Lotus to walk, can you not fall down? I think it is necessary to rethink the relationship and management mode between traditional Chinese medicine and Western medicine, traditional medicine and modern medicine, traditional Chinese medicine and national medicine from the top-level design In the past, traditional Chinese medicine was not separated, but the modern management of traditional Chinese medicine is not only an academic issue, but also a political, economic and cultural issue If we discuss traditional Chinese medicine again, the situation is more complex Therefore, this paper tries not to involve traditional Chinese medicine, and focuses on the management and development of traditional Chinese medicine In my opinion, what our country needs is not the modernization of traditional Chinese medicine, but the modern management of traditional Chinese medicine The modernization of traditional Chinese medicine has been described in the front What is the modern management of traditional Chinese medicine? In a word: scientific definition and classification, lenient drug supervision and strict medical insurance payment Through the following table, we can clearly see the difference between the modernization mode of traditional Chinese medicine and the modern management mode of traditional Chinese medicine Table 1 The difference between the modernization mode of traditional Chinese medicine and the modernization mode of traditional Chinese medicine management The modernization of traditional Chinese medicine management is based on the objective understanding of traditional Chinese medicine and the recognition of the characteristics of traditional Chinese medicine It is no longer mandatory to require traditional Chinese medicine according to the standards of modern medicine Specifically from three aspects of management: first, the scientific definition and classification of the existing Chinese patent medicine (including ethnic medicine) is divided into natural medicine and traditional medicine For natural medicine, modern medicine management method is adopted, and for traditional medicine, the strategy of lenient supervision and strict payment is adopted Definition of traditional medicine: under the guidance of traditional medical theory, traditional dosage forms and use methods, traditional indications, and drugs based on traditional evidence-based methods are adopted Definition of natural medicine: Animal Medicine, plant medicine and mineral medicine guided by modern medicine theory and verified by systematic research and clinical trials By means of simplified registration approval and re evaluation of traditional Chinese medicine injection, the existing and newly listed traditional Chinese medicine can be classified into natural medicine and traditional medicine respectively 2、 Traditional Chinese medicine supervision should be lenient and respect the tradition, no longer require traditional Chinese medicine according to the standard of modern medicine, and provide a loose development environment for the research, development, marketing and production of traditional Chinese medicine Taking CFDA's supervision on the production process of traditional Chinese medicine as an example, the regulations require that the production should be strictly in accordance with GMP, which must be completely consistent with the original application process, and the process should not be changed easily This is actually the management concept of modern drugs, because only when it is consistent with the original technology of this drug (samples for clinical trials), can the efficacy be guaranteed to be consistent It's feasible for drugs that have passed systematic clinical trials, but it's a little funny for Chinese traditional medicine Why? Because there was no systematic clinical trial research when the Chinese traditional medicine was first declared, that is, some old Chinese medicine and old pharmacists, based on their experience, equipment, conditions and knowledge at that time, came up with a process like this Is it necessary to strictly keep the source unchanged? Regulatory leniency is mainly from the perspective of market access, but it is necessary to strengthen the supervision of vague TCM instruction manuals, such as "toxic side effects", "adverse reactions" and other items in TCM instruction manuals, which are all "not clear", but the common people are misled to think that there is no toxic side effects and adverse reactions For drugs that have not been systematically studied, first, they should According to the literature and the monitoring data of adverse reactions, it is not clear that "there may be some adverse reactions, but systematic research has not been carried out" should be used instead of "it is not clear" For those containing toxic medicinal materials, the toxic side effects and adverse reactions of the toxic medicinal materials should be noted 3、 Traditional medicine medical insurance payment should be strict For traditional medicine, payment system must be strict Otherwise, traditional medicine will be in flood, a large number of "magic medicine" will waste medical resources, reduce the overall efficiency and scientificity of China's medical and health expenditure The strict traditional medicine payment system refers to the strict control of national medical insurance payment Traditional medicine is not included in or less included in the medical insurance catalogue, but it does not limit the people to pay for the purchase of traditional Chinese medicine at their own expense The use depends on the market As the payer, it is natural for social security institutions not to choose products without systematic clinical validation test If there are indeed traditional Chinese medicines that meet the requirements of modern medicine, after systematic preclinical and clinical research, they will be included in modern natural medicine management and can be paid in the medical insurance catalog Finally, the implementation path and possibility are discussed: This article is not a paper talk The statement of "the state develops medical and health undertakings, develops modern medicine and traditional medicine of our country" in the constitution of our country is accurate and scientific It is about modern medicine and traditional medicine, not western medicine and traditional Chinese medicine The supplementary provisions on the administration of the registration of traditional Chinese medicine in 2008 stipulates that "traditional Chinese medicine compound preparations derived from ancient classic prescriptions can be directly listed without clinical trials", but due to the failure to clarify the relationship between traditional medicine and modern medicine, it is blocked and criticized by most experts After nearly 10 years of suffering, the catalogue of ancient classic prescriptions will be published soon, and the compound preparations of traditional Chinese medicine classic prescriptions will be published CFDA has been asking for opinions, which means to distinguish modern medicine from traditional medicine The author has always doubted that a product without clinical trial can be called a drug? Can it be used by doctors? That's because, like most opponents, the author used to judge traditional Chinese medicine by the standard of modern medicine According to the idea of this paper, it is feasible, but an important measure - "scientific definition and classification, strict payment for medical insurance" is needed: first, such drugs are classified as traditional drugs and given a specific number of approval, such as "traditional drug standard XXXXXX", instead of directly issuing the drug number according to the current "national drug standard XXXXXX" After the reevaluation of chemical drugs, the reevaluation of Chinese patent drugs has been put on the agenda, but there is no consensus on how to evaluate them The idea of this paper can be adopted Those who can pass the verification of systematic clinical trials are included in the management of natural drugs (modern drugs), and those who cannot or fail to pass the verification of systematic clinical trials within the specified period are classified as traditional drug management Only by starting from the top-level design and implementing modern Chinese medicine management - scientific definition and classification, wide drug supervision, strict medical insurance payment, clear the difference between modern medicine and traditional medicine, traditional Chinese medicine and natural medicine, and classified management, can we be honest and clear On the one hand, the government gives a relaxed regulatory environment, and Chinese medicine can develop according to its own logic and characteristics to ensure the development of Chinese medicine Inheritance: some of the effective drugs can be proved to be modern (NATURAL) drugs, and can enter the international market to ensure the progress of traditional Chinese medicine; on the other hand, strict medical insurance payment standards can improve the social medical efficiency and reduce the medical cost.