药物临床研究阶段申办者和生产场地变更研究六:临床研究阶段申办者和生产场地跨境变更的风险分析  

ResearchⅥon the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Risk Analysis of Cross-border Changes of Sponsors or Production Sites in the Clinical Research Phase

作　　者：陈震[1,5] 王方敏 吴正宇 于冰 陈江鹏 高丽萍 杨建红 Chen Zhen;Wang Fangmin;Wu Zhengyu;Yu Bing;Chen Jiangpeng;Gao Liping;Yang Jianhong(School of Pharmacy,Zhengzhou University,Zhengzhou 450001,China;Shanghai Drug and Medical Device Adverse Reaction Monitoring Center,Shanghai 200040,China;Novo Nordisk(Shanghai)Pharmaceutical Trading Co.,Ltd.,Shanghai 200131,China;China Association of Enterprises with Foreign Investment R&Dbased Pharmaceutical Association Committee,Beijing 100020,China;Yeehong Business School,Shenyang Pharmaceutical University,Beijing 100055,China;Center for Drug Evaluation,National Medical Products Administration,Beijing 100076,China)

机构地区：[1]郑州大学药学院,郑州450001 [2]上海市药品和医疗器械不良反应监测中心,上海200040 [3]诺和诺德(上海)医药贸易有限公司,上海200131 [4]中国外商投资企业协会药品研制和开发工作委员会,北京100020 [5]沈阳药科大学亦弘商学院,北京100055 [6]国家药品监督管理局药品审评中心,北京100076

出　　处：《中国药事》2024年第5期538-548,共11页Chinese Pharmaceutical Affairs

基　　金：中国药品监督管理研究会委托亦弘商学院开展的“我国临床研究阶段申办者和生产场地变更研究”课题(编号2021-Y-Y-22)。

摘　　要：目的:通过对临床研究阶段申办者、生产场地发生跨境变更时的风险变化进行分析,为申办者和生产场地的跨境变更管理提供参考。方法:基于申办者和生产场地不同组合情形的初始风险评价结果和采取风险管控措施后的风险再评价结果,比较分析不同组合情形之间发生变更时变更前后的“风险指数水平”变化。结果与结论:基于初始风险评价结果,有两种变更情形的风险指数水平在变更后较变更前降低;基于风险再评价结果,有四种变更情形的风险指数水平在变更后较变更前降低。Objective:To evaluate and analyze the risk changes of cross-border changes in sponsors or production sites,and provide reference for the management of cross-border changes in sponsors and production sites.Methods:Based on the initial risk assessment results of different combination modes of the sponsors and production sites, and the risk re-evaluation results after implementing risk control measures, a comparativeanalysis was conducted on the changes in the "risk index level" before and after the changes occur betweendiff erent combination modes. Results and Conclusion: Based on the results of the initial risk evaluation, the riskindex levels of two change scenarios were lower after the change than before the change, and based on the resultsof the risk re-evaluation, the risk index levels of four change scenarios were lower after the change than before thechange.

关 键 词：临床研究阶段 申办者 生产场地 跨境变更 风险分析 

分 类 号：R95[医药卫生—药学]