Study on the combined utilization of new drug expedited programs in America: the empirical analysis of osimertinib's R&D and application process
DING Jin-xi
LI Peng-hui
YAO Xue-fang
Abstract：Objective:To empirically study the combined utilization of America's new drug expedited programs,in order to provide suggestions to China's system setting and improve accessibility of new drugs.Methods:The implementation performance of expedited programs was statistically analyzed.The characters of the combined utilization were empirically analyzed by using osimertinib as a typical case,thereafter suggestions were proposed.Results:The combined utilization of expedited programs could markedly accelerate the R&D process of new drugs and improve its accessibility.There were still many deficiencies in China's system.Conclusion:It is necessary to reform the drug registration system in China,strengthen the policy incentives for new drugs with breakthrough efficacy,and improve new drug accessibility of major disease types.
Keywords：new drug expedited programscombined utilizationaccessibility of new drugsosimertinib
Publication Date：2018-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：7( 1-7 )