基于熵权TOPSIS和障碍度模型的我国创新药审评审批评价OA

Objective To evaluate the development level of innovative drug review and approval in China from 2020 to 2024 and identify major obstacle factors.Methods Data were collected from annual drug review reports and annual reports on new drug registration clinical trials from 2020 to 2024.A nine-index system was constructed from four dimensions,including application activity,review and approval output,accelerated marketing support,and clinical trial support.The entropy-weighted technique for order preference by similarity to ideal solution(TOPSIS)model and obstacle degree model were used,and robustness tests were performed.Results Marketing authorization application acceptance,priority review and approval,and approved or recommended innovative drugs had relatively high weights.The comprehensive scores from 2020 to 2024 were 0.01,0.50,0.27,0.72 and 0.84,respectively,showing a fluctuating upward trend.The rankings obtained from equal-weight TOPSIS and weight perturbation analysis were consistent with the original results.The obstacle factors gradually shifted from insufficient marketing application transformation and approval output in the early stage to the precise application of conditional approval and insufficient phase Ⅲ clinical trial support.Conclusion From 2020 to 2024,the development level of innovative drug review and approval in China improved overall,but improvements across different links were not synchronous.Coordination among marketing application guidance,application of accelerated marketing procedures,and clinical evidence generation still needs to be strengthened.