Research on communication mechanism oriented by quality and efficiency in drug registration testing
ZHONG Xuanwei
XUE Jing
TIAN Xuebo
ZHANG Weimin
WANG Shan
LI Ying
JIANG Yingjun
LI Lulu
LIU Wenting
ZHAO Pengbo
HUANG Baobin
Abstract：To explore the establishment of a communication and exchange mechanism involving drug evaluation agen-cies,applicants,and drug inspection agencies in the process of drug registration testing,in order to improve the quality and efficiency of drug registration testing.From the perspective of project management,clarify the responsibilities of drug registra-tion testing participants,and analyze the influencing factors of registration testing quality and efficiency.Propose the content of the communication mechanism from four aspects:communication initiation principles,communication methods,application of communication results,and evaluation of communication effectiveness.Establish a communication and exchange mechanism involving drug review agencies,applicants,and inspection agencies to timely coordinate and solve common and individual problems in drug registration testing.The mechanism is better leverage the technical support role of registration testing in drug review.
Keywords：Drug registration testingCommunicationQuality of testingEfficiency of testingCenter for drug evaluation
Publication Date：2025-04-30
Online Publishing Date：2025-08-15(First online date of this platform, not the publication date of the document)
Pages：6( 411-416 )