Analysis on drug registration included in the priority review procedure before and after the enactment of the"Drug Registration Regulation"(2020)

WANG Shu-fang; TIAN Li-juan

doi:10.3969/j.issn.1003-3734.2024.01.003

Abstract：Objective:To compare the changes of drug registration included in the priority review procedure before and after the implement of the new Drug Registration Regulation,the impact on the changes of the regulation was analyzed and the suggestions and references were provided for further improving the priority review procedure of drugs in China.Methods:By collecting the annual drug evaluation reports and public information of drugs included in the priority review procedure published by the Center for Drug Evaluation of China Food and Drug Administration,the drug registration included in the priority review procedure from 2016 to 2022 was analyzed and evaluated.Results:The number of registration applications included in the priority review significantly increased from 2016 and reached the highest level in 2018,but dropped later.After the implement of the new Drug Registration Regulation in 2020,the number of registration applications included in the priority review remarkably decreased.Since the priority review began in 2016,the number of registration applications approved by priority review recommendations has increased year by year.After the release of the new Drug Registration Regulation,the completion rate of registration applications included in the priority evaluation procedure increased from 72.9%in 2020 to 95.2%in 2021.Conclusion:The new Drug Registration Regulation adjusted the scope of application,clarified the time limit of the priority evaluation,and optimized the procedures.More detailed procedures and requirements benefit to the implement of the system,speed up the review of new drugs and encourage the innovation of drugs with clinical value.