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Evaluation and analysis of China’s drug regulatory efficiency based on the super efficiency SBM model and Malmquist index
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Xu-hua YAN1, 2, 3, Yi-tong KE4, Jie-yi CHEN1, Yu-lun LUO1, 2, 3, Qiu ZHANG1, 2, 3
Chinese Journal of Clinical Pharmacology | 2026, 42(6) : 893 - 900
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Chinese Journal of Clinical Pharmacology | 2026, 42(6): 893-900
Regulatory Science Column
Evaluation and analysis of China’s drug regulatory efficiency based on the super efficiency SBM model and Malmquist index
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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
Published: 2026-03-28 doi: 10.13699/j.cnki.1001-6821.2026.06.022
Outline
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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.

drug safety regulation  /  efficiency evaluation  /  super efficiency SBM model  /  Malmquist index
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
Year 2026 volume 42 Issue 6
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Article Info
doi: 10.13699/j.cnki.1001-6821.2026.06.022
  • Receive Date:2026-03-18
  • Online Date:2026-08-06
  • Published:2026-03-28
Article Data
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History
  • Received:2026-03-18
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
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表12种不同金属材料的力学参数

Family
属数
Number of
genus
种数
Number of
species
占总种数比例
Percentage of
total species (%)

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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