“申请人之窗”建设在药品技术审评中发挥的作用  

On the Role of "Applicant’s Window" in Drug Review

作　　者：范乙[1] Fan Yi(Center for Drug Evaluation, National Medical Products Administration, Beijing 100022, China)

机构地区：[1]国家药品监督管理局药品审评中心

出　　处：《中国药事》2019年第7期725-731,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:通过构建"申请人之窗"栏目,充分研究利用信息化技术在药品审评工作中发挥积极的作用。方法:通过对"申请人之窗"的建设背景、技术手段、应用情况、应用场景以及作用特点等项目内容逐条分析,进而总结出其在药品审评工作中的经验与启示。结果与结论:通过信息技术的应用,"申请人之窗"在加大信息公开、降低廉政风险、建立与申请人之间的电子信息交流渠道、提升审评质量和效率方面发挥着积极作用。已经成为药品审评中心与注册申请人之间不可缺少的信息化应用平台。进一步探索了"互联网+"在药品审评中的应用和实践。Objective: To fully study the role of information technology in drug review after the establishment of the "Applicant’s Window". Methods: The experience and enlightenment in the drug review were summarized by analyzing the establishment background, technical means, application situation, application scenario and function of the "Applicant’s Window". Results and Conclusion: Through the application of information system technology, the "Applicant’s Window" plays an active role in promoting information exchange with applicants,and improving the quality and efficiency of reviews. It has become an indispensable information application platform between the Center for Drug Evaluation and registered applicants, and the application and practice of "Internet +" in drug review are further explored.

关 键 词：药品审评 申请人之窗 信息公开 互联网+ 

分 类 号：R95[医药卫生—药学]