《中医药法》与《药品管理法》有关中药保护衔接机制研究  

Research on connection mechanism of traditional Chinese medicine protection between “Traditional Chinese Medicine Law” and “Drug Administration Law”

作　　者：岳远雷[1] 王文延 YUE Yuan-lei;WANG Wen-yan(Hubei University of Chinese Medicine,Wuhan 430065,China)

机构地区：[1]湖北中医药大学,湖北武汉430065

出　　处：《中草药》2023年第6期1705-1712,共8页Chinese Traditional and Herbal Drugs

基　　金：湖北中医药大学2021年度中医药传承创新资助项目“中医药传统知识保护条例立法根基研究”;湖北省高等学校哲学社会科学研究重大项目(20ZD054)。

摘　　要：就中药保护与发展而言,《中医药法》与《药品管理法》属于特别法和一般法的关系,但也存在各自不同的适用法域。中药治理现代化及中药依法行政要求两法协调衔接,且初步形成了相关的协调衔接机制,但两法有效协调衔接还存在现实困境。构建两法协调衔接机制的核心要素应坚持职权法定、合目的性、合理性原则,应以权责明晰、程序规范、运转顺畅为建构标准。构建两法协调机制应当考虑的重要事项主要包括:抓好中药质量源头管理、优化中药审评审批管理、完善医疗机构临方炮制中药饮片管理、细化以传统工艺配制的院内制剂备案管理。As far as the protection and development of traditional Chinese medicine is concerned,Traditional Chinese Medicine Law and the Drug Administration Law belong to the relationship between special law and general law,but they also have different applicable jurisdictions.The modernization of traditional Chinese medicine governance and the administrative requirements of traditional Chinese medicine in accordance with the law require the coordination and connection of two laws.The two laws have initially formed a relevant coordination and connection mechanism,but there are still practical difficulties in effective coordination and connection of two laws.The core elements of constructing the coordination mechanism of two laws should adhere to principle of statutory authority,the principle of purposefulness,and the principle of rationality,and should be based on clear powers and responsibilities,standardized procedures,and smooth operation.Important matters that should be considered in building a coordination mechanism between two laws include:focusing on the quality source management of traditional Chinese medicines,optimizing review and approval mechanism of traditional Chinese medicines,improving management of traditional Chinese medicine decoction pieces prepared by medical institutions,and refining management of in-hospital preparations prepared by traditional techniques.

关 键 词：中医药法 药品管理法 中药保护 衔接机制 中药监管 

分 类 号：R288[医药卫生—中药学]