药品安全治理效能评估指标体系研究

Research on the Evaluation Indicator System of Drug Safety Governance Effectiveness

目的:从药品安全治理效能的角度,围绕药品安全治理目标和效率评估,探索建立适合我国国情的药品安全治理效能评估指标体系,以期促进药品治理能力现代化。方法:按照结构-过程-结果的评估模型,从治理理论出发,通过国外药品监管能力评估方法和国内药品监管法规政策及文献研究,依据专家咨询结果和层次分析法设立药品安全治理效能评估指标体系。结果与结论:药品安全治理是一个“输入-输出”的动态过程,效能反映的是药品安全治理体系运行的结果与成效。本研究初步建立了药品安全治理效能评估指标体系,以期为药品监管部门完善药品安全治理体系、提升药品监管能力提供参考。

Objective:The fundamental goal of drug safety governance is to ensure drug safety,promote the high-quality development of the pharmaceutical industry,and enhance the effectiveness of drug safety governance.This article aims to explore the establishment of an evaluation indicator system for drug safety governance effectiveness that is suitable for China's national context.It focuses on assessing the goals and efficiency of drug safety governance,in order to promote the modernization of drug governance capabilities.Methods:Using the structure-process-outcome evaluation model as a framework,this research builds an evaluation system for drug safety governance.It incorporates foreign regulatory capacity evaluation methods,domestic regulatory policies,and relevant literature,based on expert consultations and the analytic hierarchy process.Results and Conclusion:Drug safety governance is a dynamic"input-output"process,and effectiveness reflects the outcomes and achievements of the governance system's operation.This study has preliminarily established an evaluation indicator system for drug safety governance effectiveness,providing a reference for drug regulatory authorities to improve drug safety governance system and enhance drug regulatory capabilities.