药学研究2025，Vol.44Issue(4)：411-416,6.DOI:10.13506/j.cnki.jpr.2025.04.017
药品注册检验质效导向的沟通机制研究
Research on communication mechanism oriented by quality and efficiency in drug registration testing
仲宣惟 1赵芃帛 1黄宝斌 1薛晶 1田学波 1张炜敏 1王杉 1李莹 1姜英君 1李璐璐 1刘文婷1
作者信息
- 1. 中国食品药品检定研究院,北京 102629
- 折叠
摘要
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.关键词
药品注册检验/沟通交流/检验质量/检验效率/药品审评中心Key words
Drug registration testing/Communication/Quality of testing/Efficiency of testing/Center for drug evaluation分类
医药卫生引用本文复制引用
仲宣惟,赵芃帛,黄宝斌,薛晶,田学波,张炜敏,王杉,李莹,姜英君,李璐璐,刘文婷..药品注册检验质效导向的沟通机制研究[J].药学研究,2025,44(4):411-416,6.
