Analysis of the effect of the accelerated approval process for antitumor drugs in the United States and its implications for China
ZHANG Shuo
JIN Si-yu
YANG Li
Abstract：This article took all antitumor drugs approved through the accelerated approval process in the United States by March 1,2023 as research samples,and analyzed the operation effect of the accelerated approval process in the United States by dividing them into three scenarios:verified,ongoing and withdrawn.The results showed that the operation of the accelerated approval process in the United States had three characteristics:completeness,flexibility,and scientificity.This paper proposed suggestions for the improvement of China's conditional approval procedures from six aspects:perfecting the relevant contents of the laws and regulations,constructing a more comprehensive guidance system,improving the flexibility of the review procedures,strengthening the evidence system construction,encouraging the conduct of randomized controlled trials and optimizing the transition path of conditional approval to routine approval of anti-tumor drugs.
Keywords：accelerated approvalantitumor drugsconditional approvalclinical trials
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：10( 521-530 )