ZHAO Jun-ning
The regulation of traditional Chinese medicine(TCM) in China has undergone four stages of institutional evolution and scientific process: traditional quality regulation (sensory property identification), modern quality regulation (physicochemical property analysis), establishment of Chinese medicine registration standards (effectiveness, safety, and quality control technology), and scientific regulation of Chinese medicine (new tools, new standards, and new methods).Now the regulation of TCM has entered a new stage with acceleration of drug registration, throughout quality control of the entire industrial chain, technological innovation of throughout the life cycle, and global TCM regulatory coordination.This paper proposes that TCM regulatory science is the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of TCM products, by the interdisciplinary knowledge and integration research of Chinese medicine, western medicine, regulatory science, etc. It is an emerging cross-disciplinary science that accelerates the transformation of new technology products of TCM and promotes the inheritance, innovation, and development of TCM.We will further comprehensively strengthen the construction of a scientific regulatory system for TCM, address fundamental, critical, cutting-edge, and strategic technical issues related to TCM regulation,in order to establish a registration system that conforms to the characteristics of TCM, achieve a higher level of scientific rugulation of TCM, accelerate the transformation and application of new technologies and products of traditional Chinese medicine, create a strong TCM industry, and promote the inheritance and innovation of TCM.