药物临床研究阶段申办者和生产场地变更研究五:申办者和生产场地不同组合方式的风险评估和风险控制研究  

ResearchⅤon the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research on Risk Assessment and Risk Control of Diff erent Combinations of Sponsors and Production Sites

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

机构地区：[1]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 [2]国家药品监督管理局药品审评中心,北京100076 [3]上海市药品和医疗器械不良反应监测中心,上海200040 [4]诺和诺德(上海)医药贸易有限公司,上海200131 [5]沈阳药科大学亦弘商学院,北京100055 [6]郑州大学药学院,郑州450001

出　　处：《中国药事》2024年第5期526-537,共12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:对新药临床试验阶段申办者和临床试验药物生产场地的境内外不同组合方式开展风险评估和风险控制研究,为进一步完善我国临床试验阶段申办者和生产场地的跨境管理提供参考。方法:采用失效模式与效应分析及风险指数法,针对申办者和生产场地的境内外不同组合方式进行风险的识别、分析和评估。结果与结论:在新药临床试验阶段,“申办者在境内、生产场地在境外(供全球)”和“申办者在境外、生产场地在境内”是两种风险较低的跨境情形,且可通过适当措施对潜在风险进行管控,可优先考虑打通这两种跨境情形的注册路径。Objective:To conduct risk assessment and risk control research on different combinations of domestic and overseas sponsors and clinical trial drug production sites during the clinical trial phase of new drugs,and in order to provide reference for further improving the cross-border management of sponsors and production sites during the clinical trial phase in China.Methods:Failure Mode and Effect Analysis and Risk Priority Number were used to identify,analyze,and assess the risks of diff erent combinations of domestic and overseas sponsors and production sites.Results and Conclusion:During the clinical trial phase of new drugs,"the sponsor is in China while the production site is overseas(for global supply)"and"the sponsor is overseas while the production site is in China"are two low-risk cross-border situations,and potential risks can be controlled through appropriate measures.It is recommended to prioritize the registration path for these two cross-border situations.

关 键 词：药物临床试验 申办者 生产场地 风险评估 风险控制 

分 类 号：R95[医药卫生—药学]