Introduction to traditional Chinese medicine (TCM) regulatory science for TCM high-quality development

In the past decade, drug regulation science has evolved into an emerging interdisciplinary discipline, which researches and develops new tools, standards and methods to evaluate drug quality, safety and efficacy. Compared with developed countries or regions, the proposal of drug regulation science in China is relatively late, and traditional Chinese medicine (TCM) regulation science lacks the same type of regulatory research and system for reference in the world. Based on the development process of drug regulation science, the frontier progress of drug regulation science in China and the United States, the European Union, Japan and other countries and regions were summarized, and the connotation and extension of Chinese medicine regulation science were comprehensively illustrated in this paper. (1) Proposal and development of drug regulation science. Since the 19th century, national governments in different countries have re-examined the positioning and function of drug regulation due to the frequent incidents of drug harm. In 2019, the National Medical Products Administration (NMPA) launched the Scientific Action Plan for Drug Regulation in China, which is the first initiation of scientific research on TCM regulation. The connotation and extension of drug regulation science have been defined by different countries or regions based on their own national conditions or circumstances, and the corresponding strategic plans have also been designed. (2) International advances in drug regulation science. To protect and promote public health in a timely manner, the U.S. Food and Drug Administration, the European Medicines Agency, and the Japan Pharmaceuticals and Medical Devices Agency have developed and issued innovative pharmaceutical countermeasures. NMPA has rated 117 key laboratories and has been successfully elected to the Management Committee of the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use. (3) Proposal and development of TCM regulation science. In 2019, for the first time, the NMPA officially put TCM regulation into the scientific category of drug regulation. As a part of the national strategy, TCM regulatory science faces two major challenges: One is to explore the scientific nature and rationality of different regulatory models in terms of quality supervision and accessibility of TCM products; the other is to explore new tools, methods and standards for evaluation and supervision in terms of effectiveness and safety of TCM products. (4) Key tasks of TCM regulation science. Considering the national conditions, the current situation of TCM production, research, development and application and the development course of drug regulatory authorities in China, it is suggested that the scientific connotation of TCM can be studied from eight aspects: Top-level design of TCM supervision; Innovation of TCM regulatory tools; Improvement of the TCM regulatory standard system; Improvement of TCM supervision system; Strengthening the technical requirements for the supervision and control of the whole life cycle of TCM; Strengthening the intelligence construction in TCM supervision; Deepening international cooperation in the regulation of plant medicines; Cultivation of TCM supervision personnel.