Analysis of drug registration application in China from 2018 to 2022
TANG Xiang-yan
CAO Yong-fang
ZHOU Gang
Abstract：In this paper through summarizing the drug registration application data in the annual drug review reports in 2018-2022 issued by the Center of Drug Evaluation of China,the amount of acceptance,the total number of concluded application,the number of application finished on time,application for clinical trials of investigational new drugs(INDs),new drug marketing application(NDA),and the involved fields of indications of INDs were analyzed,and the change trend and causes were discussed.It was found that in 2018-2022,the received and concluded applications for INDs and NDA showed increasing trend,the enthusiasm for new drug research and development was high,and the overall on-time completion rate reached 99.80％.The efficiency of drug registration and implementation can be expected to improve,the research and development of TCM indications is relatively balanced,and the research and development of chemical drugs and biological products is mostly focused on anti-tumor drugs.The current policy environment is good,which is conducive to the R&D and innovation of all kinds of clinically urgent drugs.
Keywords：application for drug registrationclosing by time limitinvestigational new drugnew drug applicationfield of indication
Publication Date：2024-09-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：10( 1879-1888 )