层次分析法在“两品一械”监管重点实验室评价指标权重确定中的应用

目的：应用层次分析法（Analytic Hierarchy Process，AHP）确定国家药品监督管理局药品、化妆品和医疗器械监管重点实验室评价体系各指标权重，为评价提供基础数据支撑。方法：在现有评价指标体系的基础上，依据评分细则中对各指标的重要性评分，构建判断矩阵，运用层次分析法确定一、二级指标权重。结果：基础条件、人才队伍、近五年内科学研究及成果、服务监管能力和社会贡献5个一级指标的权重分别为0.0646、0.0646、0.3579、0.3579和0.1549，模型具有较好的一致性和满意度，一级指标CI为0.014，CR为0.01，二级指标各项CI和CR值均小于0.1。结论：指标权重合理体现了各指标在重点实验室综合能力组成中的相对重要程度，为国家药品监督管理局重点实验室评估提供了量化的评价依据，也为统一专家评分和实验室自评尺度以及机构间的横向比较奠定了基础，具有较高实践应用价值。

Application of Analytic Hierarchy Process in Determining the Weights of Evaluation Indicators of Key Laboratories for the Regulation of Pharmaceuticals Cosmetics and Medical Devices

Objective: To determine the weights of the indicators in the evaluation system of the key laboratories for the regulation of pharmaceuticals, cosmetics and medical devices of National Medical Products Administration (NMPA) by applying analytic hierarchy process (AHP), so as to provide basic data support for evaluation. Methods: Based on the existing evaluation indicator system, and the importance scores of each indicator in the rubrics, judgment matrixes were constructed, and the weights of the primary and secondary indicators were determined by AHP. Results: The weights for the primary indicators, such as basic conditions, the talent team, the scientific research and achievements in the past five years, the capability for serving regulation and the social contribution were 0.0646, 0.0646, 0.3579, 0.3579 and 0.1549, respectively. The model had good consistency and satisfaction. CI was 0.014 and CR was 0.01 for the primary indicator, and the CI and CR values of the secondary indicators were both less than 0.1. Conclusion: The weights for the indicators reasonably reflect the relative importance of each indicator in the comprehensive competence evaluation for key laboratories, and provide a quantitative evaluation basis for the evaluation of key laboratories of NMPA. They also lay the foundation for unified expert scoring and laboratory self-evaluation scales and the horizontal comparison between institutions and have high practical application value.