Comparison of innovative drug approvals in China and the United States in 2023
GAN Chang-jiao
YUAN Yan-fang
ZHENG Yang
YANG Yue
FANG Jun
Abstract：Objective:To compare the similarities and differences of the innovative drug and novel drug approvals in China and the United States in 2023,in order to make suggestions for the research and development(R&D),review and approval policies of innovative drugs in China.Methods:The approval types,applicants/manufacturers,targets,indications,and whether to use one or more expedited programs were compared.Results:Forty innovative drugs were approved in China in 2023 and mainly are antineoplastic and immunomodulating agents and anti-infectives for systemic use.The orphan drug R&D is insufficient compared with the United States.Conclusion:The R&D strength of innovative drug and review and approval efficiency have been further improved in China,but the innovative research and development system still needs to be improved.
Keywords：innovative drugreview and approvalinnovative drug development
Publication Date：2025-04-30
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 790-796 )