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
Research Ⅴ on the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:Research on Risk Assessment and Risk Control of Different Combinations of Sponsors and Production Sites
于冰 1杨建红 2王方敏 3吴正宇 4陈江鹏 5陈园 5陈震 6张象麟5
作者信息
- 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. 沈阳药科大学亦弘商学院,北京 100055;郑州大学药学院,郑州 450001
- 折叠
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.
Abstract
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 different 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Key words
drug clinical trial/sponsor/production site/risk assessment/risk control引用本文复制引用
基金项目
我国临床研究阶段申办者和生产场地变更研究课题(2021-Y-Y-22)
出版年
2024
NETL
NSTL
万方数据