Research on the link between expedited review and drug reevaluation from the perspective of innovation incentive based on American experience
ZHANG Li-yang
YAN Jian-zhou
SUN Yuan-yuan
SHAO Rong
Abstract：Expedited review in China has made a significant progress after years of development,but there's still a large gap in the quality and efficiency of the review compared with developed countries.This paper made an in-depth analysis of the existing problems of expedited review in China.Based on the experience from expedited review and post-marketing clinical study in the U.S.,specific suggestions were put forward to improve a multi-channel system of expedited review and establish the link between expedited review and post-marketing drug reevaluation.We expect the improvement of review efficiency and the inspiration of innovation enthusiasm through the suggestions provided by this paper.
Keywords：expedited reviewaccelerated approvalreevaluationinnovation incentivepost-marketing clinical study
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：6( 2625-2630 )