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. 2025 Jun 17;20(6):e0325924.
doi: 10.1371/journal.pone.0325924. eCollection 2025.

Quantitative evaluation and obstacle factor diagnosis of drug regulatory capacity in China

Mingming Zhai  1 , Liwen Huang  2 , Shijie Sun  1 , Liying Cao  1 , Xueqiong Yue  2 , Yuanxia Hu  3
Affiliations

Quantitative evaluation and obstacle factor diagnosis of drug regulatory capacity in China

Mingming Zhai et al. PLoS One. .

Abstract

Objective: To quantitatively evaluate the drug regulatory capacity in China, aiming to optimize the drug regulatory system, precisely enhance local regulatory effectiveness, and reduce regional regulatory disparities.

Methods: Using the methods of literature research, expert interviews, investigation and analysis, the quantitative evaluation indicator system of supervision ability was established in all directions; the indicator data were collected and quantified; the indicator weight setting algorithm of the evaluation system was improved and the indicator weight was set by combining AHP and entropy method; the differences among eastern, central, and western provincial-level regions were analyzed by variance analysis; panel data were constructed for spatio-temporal evolution analysis; obstacle factor diagnosis model was used to analyze the obstacle factors.

Results: The quantitative indicator system was constructed from five aspects: resource acquisition, function performance, learning and development, performance level and Internet application,and the relevant indicators of pharmacovigilance and risk response were analyzed at the national macro level. From the analysis of horizontal comparative variance, the comprehensive indicator and resource acquisition indicator of various provincial-level regions were significantly different(P < 0.05), while others were not significant. From the perspective of dynamic development, except for the performance level in 2022, all provincial-level regions were generally on the rise. From the perspective of obstacle factors, they were mainly in the aspects of learning development and functional performance. Regarding national pharmacovigilance and risk response, despite the synergistic development of all links ensuring drug safety and promoting industrial progress, new issues and challenges demand continuous attention and optimization of the regulatory system.

Conclusion: There are regional differences in drug regulation in China. A drug regulation capacity improvement plan should be formulated in combination with the characteristics of the city itself and obstacle factors to achieve efficient and balanced development of drug regulation.

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Conflict of interest statement

We declare that we have no conflict of interest.

Figures

Fig 1
Fig 1. Comparison chart of different city category coefficients.
Fig 2
Fig 2. Dynamic development chart of indices of the eastern, central, western and national regions.
Fig 3
Fig 3. Trend chart of the number of adverse reaction reports.
See this image and copyright information in PMC

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