Research on the Construction of Drug Inspection Evaluation Indicator System  

作　　者：Hu Di Liao Ping Zhu Xin Dai Yuemin Ge Yuanyuan Chen Yuwen 

机构地区：[1]School of Business Administration,Shenyang Pharmaceutical University,Shenyang 110016,China [2]Shanghai Center of Drug Evaluation and Inspection,Shanghai 201210,China

出　　处：《Asian Journal of Social Pharmacy》2024年第4期327-343,共17页亚洲社会药学（英文）

摘　　要：Objective To study a way to establish a drug inspection evaluation system in China.Methods Through literature research,behavioral event interviews,Delphi expert interviews,and other methods,the theory of“threedimensional quality structure model”was used to extract,screen,and construct a set of evaluation indicator system for drug inspection,including 3 first-level indicators,11 second-level indicators,and 47 third-level indicators.Results and Conclusion An effective management tool to evaluate the quality of drug inspection has not yet been formed in China.According to the requirements of laws,regulations,and departmental rules,combined with the mature drug inspection mechanism of international drug regulatory agencies or organizations and the international quality management theory,some management tools are put forward to improve the quality system of drug supervision.

关 键 词：drug inspection QUALITY evaluation indicator system three-dimensional quality structure model DELPHI 

分 类 号：R95[医药卫生—药学]