The Party Central Committee and the State Council attach great importance to the cause of Chinese medicine, positioning Chinese medicine as unique health resources, economic resources with huge potential, scientific and technological resources with original advantages, excellent cultural resources and important ecological resources. General Secretary Xi Jinping has given important instructions to the work of traditional Chinese medicine many times, emphasizing that it is necessary to follow the law of traditional Chinese medicine development, inherit the essence, maintain integrity and innovation, and give full play to the unique advantages and effects of traditional Chinese medicine in disease prevention and treatment.  

Since the outbreak of the new crown pneumonia epidemic, traditional Chinese medicine has demonstrated its unique advantages in fighting the epidemic, contributing Chinese wisdom and traditional Chinese medicine solutions to human health. How to effectively and fully develop and utilize traditional Chinese medicine, an original resource with unique advantages, is a key issue that Chinese medicine workers must think about and solve. The research of new Chinese medicine is also an important field in the development of Chinese medicine. It is full of challenges and is worthy of the efforts of the majority of scientific researchers. The research and development of Chinese medicine must follow the characteristics and research rules of Chinese medicine, adhere to the theoretical guidance of Chinese medicine, pay attention to the holistic view and original thinking of Chinese medicine, pay attention to the basis of clinical practice, and give play to the unique advantages and effects of Chinese medicine in disease prevention and treatment. 

On September 28, 2020, the State Food and Drug Administration issued a new "Registration Classification and Application Information Requirements for Traditional Chinese Medicines" (referred to as "Registration Classification"). The "Registration Classification" deeply summarizes the practical experience of Chinese medicine review and approval, pays equal attention to the inheritance and innovation of Chinese medicine, maximizes the potential of Chinese medicine innovation, and integrates the overall concept of Chinese medicine, human experience, compound medicine and other advantages and characteristics into Chinese medicine registration management Among them, the research and development of traditional Chinese medicine can better reflect the characteristics of traditional Chinese medicine, and the general requirements of "safe, effective, and controllable quality" medicines are organically combined with the unique theoretical system and practical characteristics of traditional Chinese medicine inheritance and innovation, and the development of traditional Chinese medicine characteristics The registration review path.

First, inherit the essence of classical medical books and promote the transformation of new Chinese medicines. Traditional Chinese medicine has thousands of years of clinical medication experience. Classical prescriptions are the basis of clinical prescriptions and the source of new Chinese medicine creation. They have unique original thinking and should pay attention to the discovery of ancient literature and clinical medication experience. The research and development of new Chinese medicines is significantly different from the research and development model of chemical drugs. The "Registration Classification" adds the new registration classification of "Ancient Classical Famous Formulas of Chinese Medicine Compound Preparations", which not only exerts the original advantages of traditional Chinese medicine, but also promotes the transformation of ancient classics into new traditional Chinese medicines, forming its own unique original results, which will be beneficial to the people of my country and the world Major contribution.

Secondly, based on the inheritance of clinical value, emphasis on the collection of human empirical evidence. The human experience of traditional Chinese medicine is formed in the long-term clinical practice of traditional Chinese medicine, and it has certain regularity and repeatability. The summary of experience about Chinese medicine and diagnosis and treatment is also a characteristic of Chinese medicine. The new "Registration Classification" focuses on meeting unmet clinical needs, evaluating the effectiveness of traditional Chinese medicine based on the combination of traditional Chinese medicine theory and clinical practice experience, supporting the degree of support for the safety and effectiveness of medicines based on human experience, and scientific and reasonable reductions Corresponding application materials will apply the most advantageous clinical practice of TCM to the review and approval of TCM to the greatest extent, and the summary of TCM clinical practice will play an increasingly important role in the review and review of new TCM drug registration.  Innovative traditional Chinese medicines, randomized controlled clinical trials should be conducted before marketing. For the ancient classic Chinese medicine compound preparations, review and approve new Chinese medicines from the perspective of Chinese medicine theory, and use Chinese medicine terminology for function and indication, thus opening up a path of declaration with Chinese medicine characteristics and enriching the practice of new Chinese medicine development.  

Third, respect the law of Chinese medicine research and development and support the research and development of Chinese medicine compound preparations. Traditional Chinese medicine prescriptions comprehensively regulate the body's multiple systems, multiple pathways, and multiple targets through a variety of effective components. It has the advantages and characteristics of diagnosis and treatment such as holistic concept, syndrome differentiation and treatment, individual treatment, and compound medicine. The "Registration Classification" follows the development of Chinese medicine. Laws, highlighting the characteristics of traditional Chinese medicines, and optimizing the classification of traditional Chinese medicines based on the product characteristics, innovation level and review management needs of registered Chinese medicines.  

Fourth, pay attention to the excavation of the clinical value of "old drugs" and encourage secondary development. The development of new drugs is a process from nothing to the creation of the drug's clinical value with the goal of product launching. Encouraging secondary development is to reshape the value based on clinical practice under the premise that the prescription, function and indication are fixed, and it is a process from existence to excellence. The work of excavating clinical value, shaping clinical positioning, and enhancing clinical value is the core content of the reshaping process of drug value. The "Registration Classification" broadens the scope of improved new drugs, encourages drug marketing license holders to conduct research on listed Chinese medicines, promotes the improvement and quality improvement of listed Chinese medicines, and promotes the high-quality development of the Chinese medicine industry. It not only laid a solid foundation for Chinese medicine to go global, but also opened up new fields for Chinese medicine innovation.  

Under the guidance of government departments, the establishment of a Chinese medicine innovation cooperation platform oriented by clinical efficacy, with new Chinese medicine research and development projects as the link, and integration of production, education, research and medicine can improve the quality of research and development and the success rate of research and development, accelerate the research and development of new Chinese medicines, and promote the Chinese medicine industry High-quality development. (Source of manuscript: China Medical News)