[TCM regulatory science: concepts, features, and scope]

TCM regulatory science is an important pillar for the modernization of TCM regulation. Scientifically defining its concept, clarifying its key characteristics, and delineating its research scope constitute the foundation for advancing the construction of the TCM regulatory science system. Based on reviewing the developmental trajectory of pharmaceutical regulatory science and clarifying its connections and distinctions with TCM regulatory science, this study proposes that TCM regulatory science is a discipline guided by TCM theory, integrating theories, methods, and technologies from multiple disciplines to systematically study the tools, standards, methods, and policy-support systems applicable to the development and life-cycle regulation of TCM, thereby providing scientific evidence for regulatory decision-making and institutional optimization. It has five core features, including interdisciplinary integration led by TCM theory; tool innovation and data-driven approaches; problem orientation and translational application; dynamic evolution and forward-looking guidance; and public health orientation with risk balancing. Its research scope mainly includes three aspects including tools, standards, and methodologies for TCM research and regulation; data science and analytical technologies; and translation and system optimization of TCM regulatory science. The results can provide theoretical support for building a regulatory system in line with TCM characteristics and for formulating relevant policies, thereby contributing to the modernization of TCM regulation.