Progress in the implementation of conditional approval process for drugs in China:a pooled analysis from 2020 to 2024
WANG Li
ZHAO Xiang-qi
LIAN Gui-yu
HUANG Zhe
Abstract：Objective:To conduct a comprehensive analysis of drugs marketed through the conditional approval process in China from 2020 to 2024,along with recommendations for improving this process.Methods:Drugs conditionally approved during the study period were identified through the National Medical Products Administration public data,the Center for Drug Evaluation public data,and the Yaozhi Database.The basic information,pre-market clinical trial studies,and post-marketing study requirements and progress were collected and analyzed.Results:A total of 143 approved matters were marketed through the conditional approval process.Key characteristics included:R&D resources were highly concentrated on antineoplastic drugs,a high percentage of applications in pre-market pivotal clinical trials were based on surrogate endpoints,and the conversion rate of drugs from conditional approval to full approval was low.Conclusion:It is necessary to strengthen the guidance provided by drug regulatory and relevant departments,establish a system for recognizing surrogate endpoints,and improve the flexibility of the conditional approval process.
Keywords：conditional approvalapproved drugbasic informationclinical trialspost-marketing study
Publication Date：2026-07-15
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 1372-1377 )