Analysis of drug registrations included in the priority review and approval procedure in China
ZHOU Peng
REN Si-ning
LIU Yuan
HUANG Zhe
Abstract：Objective:To summarize the development process of China's Priority Review and Approval(PRA)system,summarize the registration situation of drugs included in the Priority Review and Approval Procedure(PRAP)in China since the release of"Food and Drug Administration[2016]No.19"from February,2016 to December 31st,2022,and analyze the registration of drugs included in PRAP at different stages of system development.Methods:Based on China's published laws and regulations related to the drug PRA system,the development process of the system was sorted out.The drug registration applications included in PRAP published in the"List of Drugs Included in Priority Review"column on the website of the Center for Drug Evaluation of the National Medical Products Administration(in terms of Acceptance Numbers)were used as the data source for data analysis.Statistical analysis was carried out on the number and types of drug registrations,drug registration application items,drug therapeutic fields,the number of pediatric drug registrations,and the number of drug registrations for rare diseases included in PRAP at different stages.Results:China's drug PRA system has gone through the three stages of"seeds of system(SS),resolving the backlog(RB),and deepening the reform(DR)",and has now entered the stage of"innovative development(ID)".By the end of December,2022,a total of 1 400 drug registration applications had been included in the PRAP,including 112 active pharmaceutical ingredients(APIs)and 1 288 drugs(275 biologics,1 004 chemicals,and 9 traditional chinese medicines(TCMs).The overall quantity and proportion of chemicals had an absolute advantage.The proportion of biologics was stable in RB and DR stages,and increased significantly after entering the ID stage.As for the TCMs,not only the number was small,but also the proportion was on the decline.In the RB and DR stages,clinical trial applications(CTAs),marketing authorization applications(MAAs)and supplementary applications(SAs)were included in the registration applications.However,after entering the ID stage,the application items were all MAAs.Among the top 5 drug therapeutic areas included in PRAPs at three different development stages,antineoplastic drugs and endocrine and metabolic system disease drugs were always the hotspots for application.The number of pediatric and rare disease drug registrations included in PRAP was on the rise.Conclusion:PRAP has played a crucial role in solving the backlog of the drug reviews for biologics and chemicals,speeding up the marketing process,meeting the urgent clinical needs for therapeutic drugs,and promoting the public health.It has also improved the registration and surveillance level of drugs for pediatric and rare diseases in China.Meanwhile,there are very few varieties of TCMs included in PRAP.We see an urgent need to strengthen its research and development(R&D)and supervision.PRAP is one of the effective measures to promote the R&D and marketing of drugs for pediatric and rare diseases.Whereas multiple measures are needed to fully stimulate the attention and investment of pharmaceutical companies.
Keywords：drug priority review and approval systemdevelopment historypriority review and approval proceduredrug registrationsituation analysis
Publication Date：2024-03-31
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：9( 534-542 )