OBJECTIVE To explain the main content of the Special Regulations on the Management of Traditional Chinese Medicine Standards and propose suggestions on management of traditional Chinese medicine standards. METHODS The main content and key features of the Special Regulations on the Management of Traditional Chinese Medicine Standards was analyzed, and the suggestions were proposed to strengthen the management of traditional Chinese medicine standards. RESULTS The Special Regulations on the Management of Traditional Chinese Medicine Standards was focused on the reform of mechanism of management of Chinese medicine standards, such as building standard system that conforms to the key characteristics of traditional Chinese medicine, optimizing the management program of traditional Chinese medicine standards, clarifying the responsibilities of interested parties, and improving the technical system of traditional Chinese medicine standards. CONCLUSION The mechanism for traditional Chinese medicine standards should be optimized, the technical requirements related to traditional Chinese medicine standards should be improved, and all kinds of standards should be coordinated.

OBJECTIVE To establish a Chinese medicine standard based onprocessing, reflect the quality characteristics of Chinese medicine decoction pieces and provide a basis forquality control andevaluation of Chinese medicine decoction piece. METHODS Encouraged by the Special Regulations on the Management of Traditional Chinese Medicine Standards, highlighting the characteristics of traditional Chinese medicine processing and emphasizing the research and inheritance of traditional processing experience as the guiding principle, taking Chinese medicine processing technology as the starting point for establishing quality standards for Chinese medicine decoction pieces, summarizing processing experience and technology, comprehensively proposing the items and indicators that should be paid attention to in the standard formulation process, and making suggestions based on the problems existing in the current Chinese medicine decoction piece quality standards.RESULTS Establishing Chinese medicine standards that meet the quality characteristics of traditional Chinese medicine decoction pieces should be able to explain the scientific connotation of processing, with a focus on the changes in chemical composition or component groups caused by different processing purposes. In addition, attention should be paid to the scientificity and specificity of indicators, their correlation with drug efficacy, and their content limits.CONCLUSION It is recommended to conduct comprehensive and in-depth research to grasp the changes in the material basis of traditional Chinese medicine decoction pieces before and after processing, establish scientific, reasonable, and feasible quality control projects and indicators, and achieve control and evaluation of the quality of traditional Chinese medicine.

In recent years, National Medical Products Administration has successively issued special documents such as “Several Measures to Further Strengthen the Scientific Regulation of Traditional Chinese Medicine(TCM) and Promote the Inheritance, Innovation and Development of TCM”, “Special Regulations on Registration and Management of TCM” and “Special Regulations on the Management of TCM Standards”, which put forward new requirements for the research, formulation and management of TCM standards, and is of great significance for the comprehensive construction of a new system for the management of TCM standards, the establishment of the most rigorous TCM standards, and the promotion of high-quality development of TCM industry. Due to the natural source of TCM, the complex composition of drug components, the unique theoretical system and the safety and effectiveness derived from clinical practice, it is difficult to objectively evaluate and effectively control the quality of TCM preparations based on qualitative and quantitative quality control models based on chemical components and the quality standards established thereby. How to realize the advanced characterization and objective identification of TCM quality based on the characteristics of TCM, and to study and establish the corresponding quality standard of TCM preparation has become an important content of TCM quality research, the focus and difficulty of TCM supervision scientific research, and the bottleneck of TCM quality improvement and standard formulation. At present, the quality control of TCM preparations has established a whole process quality control system from TCM crude drugs, decoction pieces to preparations, and formed a quality standard system of TCM preparations based on the characteristics of TCM consisting of the standards of TCM crude drugs, decoction pieces, extracts and preparations. By sorting out the development history of TCM quality standards, this paper analyzs the problems and challenges in the research of TCM quality standards, and discusss the strategies and methods for the research of TCM preparation quality standards based on the characteristics of TCM in combination with the scientific research results of TCM regulatory science in recent years, and the actual research and development and review of TCM, so as to provide reference for colleagues in the industry.

OBJECTIVE To strengthen the role of Chinese medicine standards in ensuring drug quality, based on the analysis of Special Regulations on the Management of Traditional Chinese Medicine Standards, propose the suggestions on establishment of standard system conforming to the characteristics of traditional Chinese medicine. METHODS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine was analyzed, the basic considerations for construction of traditional Chinese medicine standard system were proposed. RESULTS The scientific connotation of standard system conforming to the characteristics of traditional Chinese medicine mainly includes respecting the tradition of Chinese medicine, complying with the theory of traditional Chinese medicine and observing the objective laws of traditional Chinese medicine. CONCLUSION In the process of establishment of standard system conforming to the characteristics of traditional Chinese medicine, the quality control strategies of comprehensive quality evaluation and key quality factors should be persisted, the quality control strategies of inheritance and innovation should be persisted. Moreover, the traditional thinking of Chinese medicine should be reflected in Chinese medicine standards.