Has the Reform of China's Drug Evaluation and Approval System Improved the Efficiency of Drug Evaluation and Approval Processes? – Based on ARIMA Model and Pre-post Comparison Analysis

Objective: To assess the impact of the "Reform of the Drug Evaluation and Approval System" policy on enhancing the efficiency of drug registration evaluation and approval processes. Methods: This study employed the number of pending applications for traditional Chinese medicines(TCM), chemical drugs, and biological products, along with their annual growth rates, to gauge improvements in efficiency. The ARIMA model was used to forecast efficiency levels in the absence of the policy. A comparative analysis of "Pre-post" data was conducted to evaluate the policy's effectiveness. Results: Following the issuance of Document No. 44 by the State Council of China on August 9, 2015, there was a significant reduction in the number of pending drug applications in 2016, deviating from the projected values. By the end of 2018, the discrepancy between actual and projected pending applications was 55.94% for chemical drugs, 68.02% for TCM by 2023, and 36.67% for biological products by 2022. Conclusion: The drug registration application backlog was effectively cleared by the end of 2016. The policy has led to a marked improvement in the efficiency of chemical and TCM registration evaluations, although additional efforts are required for biological products. Since 2018, the annual balance between the number of accepted and evaluated applications has been maintained, indicating the policy's success in enhancing the efficiency of drug registration evaluation and approval processes.