Research on priority review of new drugs in China
DING Jin-xi
LI Su-ju
YAO Xue-fang
GAO Lei
REN Hong-ye
Abstract:This paper,based on the special approval system which is the predecessor of present priority review of new drugs,constructed an evaluation system to review the performance of the special approval system,took consideration of our national conditions and special reform objectives of drug evaluation referring to abroad priority review mode,ultimately put forward the improved suggestions of priority review mode.It was suggested to improve the evaluation mode by refining categories of applicable conditions,accelerating setting time nodes and cultivating drug evaluation teams.
Keywords:new drugpriority reviewspecial approval systemavailability
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( 872-877 )
