| 于冰,杨建红,王方敏,吴正宇,陈江鹏,陈园,陈震,张象麟.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[J].中国药事,2024,38(5):526-537 |
| 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 ClinicalResearch Phase of Drugs: Research on Risk Assessment and Risk Control ofDiff erent Combinations of Sponsors and Production Sites |
| 投稿时间：2023-12-11 |
| DOI：10.16153/j.1002-7777.2024.05.005 |
| 中文关键词: 药物临床试验 申办者 生产场地 风险评估 风险控制 |
| 英文关键词: drug clinical trial sponsor production site risk assessment risk control |
| 基金项目: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） |
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| 中文摘要: |
| 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。 |
| 英文摘要: |
| 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 productionsites during the clinical trial phase in China. Methods: Failure Mode and Effect Analysis and Risk PriorityNumber were used to identify, analyze, and assess the risks of diff erent combinations of domestic and overseassponsors and production sites. Results and Conclusion: During the clinical trial phase of new drugs, "the sponsoris in China while the production site is overseas (for global supply)" and "the sponsor is overseas while theproduction site is in China" are two low-risk cross-border situations, and potential risks can be controlled throughappropriate measures. It is recommended to prioritize the registration path for these two cross-border situations. |
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