中国临床药理学杂志

基于超效率SBM模型和Malmquist指数的我国药品监管效率评价分析

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严许华 ¹^,²^,³ , 柯依橦 ⁴ , 陈洁仪 ¹ , 罗寓伦 ¹^,²^,³ , 张秋 ¹^,²^,³

中国临床药理学杂志 | 药物监管科学专栏 2026,42(6): 893-900

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中国临床药理学杂志 |药物监管科学专栏 2026 , 42 (6) : 893 -900

基于超效率SBM模型和Malmquist指数的我国药品监管效率评价分析

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严许华¹^,²^,³, 柯依橦⁴, 陈洁仪¹, 罗寓伦¹^,²^,³, 张秋¹^,²^,³

作者信息

^1.广东药科大学医药商学院，广东广州 510006

^2.广东省药品监管科学研究基地，广东广州 510006

^3.广东省卫生经济与健康促进研究中心，广东广州 510006

^4.广东药科大学药学院，广东广州 510006

通讯作者:

张秋，副教授 MP: 13922297358 E-mail: zhangqiu@gdpu.edu.cn

作者简介:

严许华（2003-），男，主要从事卫生经济与健康促进相关研究

Evaluation and analysis of China’s drug regulatory efficiency based on the super efficiency SBM model and Malmquist index

Xu-hua YAN¹^,²^,³, Yi-tong KE⁴, Jie-yi CHEN¹, Yu-lun LUO¹^,²^,³, Qiu ZHANG¹^,²^,³

Affiliations

^1.School of Pharmaceutical Business, Guangdong Pharmaceutical University, Guangzhou 510006, Guangdong Province, China

^2.Guangdong Research Base for Drug Regulatory Science, Guangzhou 510006, Guangdong Province, China

^3.Guangdong Research Center for Health Economics and Health Promotion, Guangzhou 510006, Guangdong Province, China

^4.School of Pharmacy, Guangdong Pharmaceutical University, Guangzhou 510006, Guangdong Province, China

出版时间: 2026-03-28 doi: 10.13699/j.cnki.1001-6821.2026.06.022

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摘要

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目的

提升药品监管效能、优化资源配置推进是药品监管现代化的核心战略。目的评价“十四五”期间（2021~2024年）我国药品安全监管的效率，分析监管资源配置与产出效果的匹配性，识别效率变化趋势及区域差异，为衔接“十四五”成效与“十五五”发展需求，优化药品监管体系提供建议。

方法

收集2021~2024年药品安全监管投入与产出数据，采用超效率SBM模型和Malmquist指数，对全国7个行政区域9个省份的药品安全监管效率进行测算分析。

结果

各省效率差异显著，辽宁持续高效，广东稳步提升，上海则持续低迷。松弛变量分析揭示，北京、上海存在显著的投入冗余与产出不足。动态来看，仅广东、广西、陕西三地全要素生产率（TFP）实现正增长，主要驱动力为技术进步（TC>1）；而湖南、贵州等地因技术效率（EC）下滑导致TFP退步，凸显监管效能提升进程存在显著的区域与技术不平衡。

结论

“十四五”期间我国药品安全监管效率较“十三五”整体提升，但存在区域失衡、纯技术效率滞后及规模配置效益递减等问题。应推动药品监管体系向精准化与智能化转型，加强监管人才队伍建设，促进监管资源与产业分布相适配。

关键词

药品安全监管 / 效率评价 / 超效率SBM模型 / Malmquist指数

Abstract

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Objective

Enhancing the effectiveness of drug regulation and optimizing resource allocation represent core strategies for advancing drug regulatory modernization. To evaluate the efficiency of drug safety regulation in China during the “14th Five-Year Plan” period (2021–2024), analyze the alignment between regulatory resource allocation and output outcomes, identify trends in efficiency changes and regional disparities, and provide recommendations for optimizing the drug regulatory system by bridging the achievements of the “14th Five-Year Plan” with the developmental needs of the “15th Five-Year Plan”.

Methods

Data on drug safety regulatory inputs and outputs from 2021 to 2024 were collected. The super-efficiency SBM (slack-based measure) model and Malmquist index were used to measure and analyze drug safety regulatory efficiency across nine provinces in seven administrative regions.

Results

Significant interprovincial efficiency variations were observed. Liaoning maintained consistently high efficiency, Guangdong showed steady improvement, while Shanghai remained persistently low. Slack variable analysis revealed notable input redundancy and output insufficiency in Beijing and Shanghai. Dynamically, only Guangdong, Guangxi, and Shanxi achieved positive growth in total factor productivity (TFP), primarily driven by technological progress (TC>1). In contrast, regions such as Hunan and Guizhou experienced TFP decline due to decreased technical efficiency (EC<1), highlighting significant regional and technological imbalances in the process of improving regulatory effectiveness.

Conclusion

During the “14th Five-Year Plan” period, the efficiency of drug safety regulation in China has seen overall improvement compared to the “13th Five-Year Plan” period. However, challenges such as regional imbalances, lagging pure technical efficiency, and diminishing returns on scale allocation remain. It is essential to advance the transformation of the drug regulatory system toward precision and intelligence, strengthen the development of regulatory talent, and ensure the alignment of regulatory resources with industrial distribution.

Key words

drug safety regulation / efficiency evaluation / super efficiency SBM model / Malmquist index

引用本文

严许华, 柯依橦, 陈洁仪, 罗寓伦, 张秋. 基于超效率SBM模型和Malmquist指数的我国药品监管效率评价分析. 中国临床药理学杂志, 2026 , 42 (6) : 893 -900 . DOI: 10.13699/j.cnki.1001-6821.2026.06.022

Xu-hua YAN, Yi-tong KE, Jie-yi CHEN, Yu-lun LUO, Qiu ZHANG. Evaluation and analysis of China’s drug regulatory efficiency based on the super efficiency SBM model and Malmquist index[J]. Chinese Journal of Clinical Pharmacology, 2026 , 42 (6) : 893 -900 . DOI: 10.13699/j.cnki.1001-6821.2026.06.022

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2026年第42卷第6期

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文章信息

doi: 10.13699/j.cnki.1001-6821.2026.06.022

接收时间：2026-03-18
首发时间：2026-08-06
出版时间：2026-03-28

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收稿日期：2026-03-18

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作者信息

^1.广东药科大学医药商学院，广东广州 510006

^2.广东省药品监管科学研究基地，广东广州 510006

^3.广东省卫生经济与健康促进研究中心，广东广州 510006

^4.广东药科大学药学院，广东广州 510006

通讯作者:

张秋，副教授 MP: 13922297358 E-mail: zhangqiu@gdpu.edu.cn

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https://castjournals.cast.org.cn/joweb/zglcylxzz/CN/10.13699/j.cnki.1001-6821.2026.06.022

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2种不同金属材料的力学参数

科 Family	属数 Number of genus	种数 Number of species	占总种数比例 Percentage of total species (%)	属 Genus	种数 Number of species	占总种数比例 Percentage of total species (%)
鹅膏菌科Amanitaceae	2	11	5.26	鹅膏菌属 Amanita	10	4.78
小菇科 Mycenaceae	2	12	5.74	丝盖伞属 Inocybe	5	2.39
多孔菌科 Polyporaceae	8	14	6.70	蜡蘑属 Laccaria	5	2.39
红菇科 Russulaceae	3	23	11.00	小皮伞属 Marasmius	6	2.87
				小菇属 Mycena	11	5.26
				光柄菇属 Pluteus	5	2.39
				红菇属 Russula	17	8.13
				栓菌属 Trametes	5	2.39

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