【摘要】 剖析我国药品监管框架下中药相关法律概念的界定现状，探讨存在的主要问题。方法 采用文献研究法，系统梳理分析相关法规文件及学术文献。结果 现行药品监管框架下的中药法律概念存在法律渊源不充分、概念体系化建构待加强、法律概念与学术概念边界待厘清等问题，一定程度增加中药监管复杂性。结论 完善中药法律概念体系是构建符合中药特点监管制度的关键。建议修订《中华人民共和国药品管理法实施条例》时，明确中药法律概念的内涵与外延，构建体系化的中药监管术语框架，并厘清法律与学术概念边界，以满足执法实际需求并推动中药产业健康发展。更多还原

【Abstract】 OBJECTIVE To analyze the definition of traditional Chinese medicine(TCM) legal concepts within the pharmaceutical regulatory framework in China and explore existing issues. METHODS Document review was used to systematically review and analyze relevant legal documents and academic literature. RESULTS Current TCM legal concepts are characterized by inadequate legal origins, insufficient systematization of concepts, and blurred boundaries between legal and academic concepts, which have increased regulatory complexity. CONCLUSION Refining TCM legal concepts is essential for establishing a regulatory system that suits TCM characteristics. During the revision of the Implementing Regulations of the Drug Administration Law of the People′s Repubic of China, the connotation and scope of TCM legal concepts should be clarified, a systematic framework of TCM regulatory terminology should be established, and the boundaries between legal and academic concepts should be clarified, so as to meet practical regulatory needs and promote the healthy development of the TCM industry.更多还原