美国FDA药品监管科学合作模式  

Cooperation model of FDA′s drug regulatory science

作　　者：乔佳慧 吴迪 韦彦伊 陈玉文[1] QIAO Jiahui;WU Di;WEI Yanyi;CHEN Yuwen(College of Business Administration/Research Institute of Drug Regulatory Science,Shenyang Pharmaceutical University,Shenyang 110016,China)

机构地区：[1]沈阳药科大学工商管理学院/药品监管科学研究院,辽宁沈阳110016

出　　处：《沈阳药科大学学报》2023年第11期1523-1529,共7页Journal of Shenyang Pharmaceutical University

基　　金：沈阳药科大学药品监管科学研究院专项基金(2021jgkx004)。

摘　　要：目的明确美国FDA在药品监管科学研究中实施的合作模式,为我国药品监管科学的发展提供参考和借鉴。方法在对美国FDA药品监管科学的内容进行检索分析的基础上,结合监管科学合作实例对美国药品监管科学合作模式进行归纳研究。结果药品监管科学已经逐步成为美国FDA关注的重点领域,FDA在推进药品监管科学过程中采用了转让内部技术、直接提供资助和融合多方资源这三种合作模式。结论由于药品监管科学的综合性和交叉性,合作模式在FDA药品监管科学发展的过程中发挥着重要的作用。我国监管机构可以设立专门的部门来推动监管科学的合作,同时鼓励和扶持药品监管科学领域第三方机构的发展。Objective To discuss the cooperation model implemented by the US FDA in drug regulatory science research and to provides reference and inspiration for the development of drug regulatory science in China.Methods Based on the retrieval and analysis of the content of drug regulatory science of FDA,the cooperation mode of drug regulatory science in the United States was summarized and studied with the examples of cooperation of regulatory science.Results Drug regulatory science has gradually become the focus of FDA′s attention.In the process of promoting drug regulatory science,FDA adopts three cooperation modes:the transfer of internal technology,the direct provision of funding and the integration of multi-party resources.Conclusion Because of the comprehensiveness and intersections of drug regulatory science,cooperation mode plays an important role in the development of drug regulatory science of FDA.China′s regulatory agencies can establish specialized departments to promote cooperation in regulatory science,while encouraging and supporting the development of third-party institutions in the field of drug regulatory science.

关 键 词：药品监管科学 合作模式 美国食品药品监督管理局 

分 类 号：R95[医药卫生—药学]