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。
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.
作者
瞿礼萍
李丹
邹文俊
杨男
宋民宪
闵志强
张廷模
QU Liping;LI Dan;ZOU Wenjun;YANG Nan;SONG Minxian;MING Zhiqiang;ZHANG Tingmo(State Key Laboratory of Southwestern Chinese Medicine Resources,Chengdu University of Traditional Chinese Medicine,Chengdu 610037,China;Sichuan Center for Regulatory Sciences in Traditional Chinese Medicine,Chengdu 611137,China;West China School of Pharmacy,Sichuan University,Chengdu 610065,China;Beijing Dongwei(Chengdu)Law Firms,Chengdu 610065,China)
出处
《中国药学杂志》
北大核心
2025年第11期1215-1220,共6页
Chinese Pharmaceutical Journal
基金
国家社会科学基金青年项目资助(18CGJ036)
第七批全国老中医药专家学术经验继承工作项目资助
第四届四川省十大名中医张廷模工作室项目资助
四川省科技计划项目资助(2023JDR0242)
四川省社会科学重点研究基地·四川中医药发展研究中心项目资助(STDYB202411)。
关键词
监管科学
中药
法律概念
法律渊源
概念体系
学术概念
regulatory science
traditional Chinese medicine
legal concept
legal origin
conceptual framework
academic concept
作者简介
瞿礼萍,女,博士,副教授,研究方向:药品监管科学及中药国际化;通信作者:闵志强,男,博士,讲师,研究方向:临床中药学,Tel:(028)61800231。
