| 于冰,杨建红,夏雨,李圆圆,顾瑶华,芦臣书,高丽萍,张元媛,王方敏.药物临床研究阶段申办者和生产场地变更研究四:我国临床研究阶段申办者和生产场地变更现状调研分析[J].中国药事,2024,38(5):516-525 |
| 药物临床研究阶段申办者和生产场地变更研究四:我国临床研究阶段申办者和生产场地变更现状调研分析 |
| Research Ⅳ on the Changes of Sponsors and Production Sites during theClinical Research Phase of Drugs: Research and Analysis on the CurrentSituation of Sponsor and Production Site Changes in the Clinical ResearchPhase in China |
| 投稿时间：2023-12-11 |
| DOI：10.16153/j.1002-7777.2024.05.004 |
| 中文关键词: 临床试验 变更管理 申办者变更 生产场地变更 药品注册 |
| 英文关键词: clinical trial change management sponsor change production site change drug registration |
| 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：梳理我国药物临床试验及临床试验期间变更管理的法规监管要求并对行业现状进行调研，为完善药物临床试验及临床试验期间变更管理的监管体系提供参考。方法：对我国临床试验及其变更的监管法规进行文献研究，对行业现状进行调研，为后续完善我国临床试验及临床试验期间变更管理提供参考建议。结果与结论：我国近年来药品审评审批改革不断完善，当前行业发展中存在申办者及生产产地“跨境”及变更的需求。综合考虑创新发展的现实需求和现有法规，在风险可控的条件下，我国已具备一定基础支持临床试验申办者和临床试验药物生产场地的“跨境”及“跨境变更”。 |
| 英文摘要: |
| Objective: To provide reference for improving the regulatory system of drug clinical trials andchange management during clinical trials by reviewing the corresponding regulatory requirements in China andinvestigating the current situation of the industry. Methods: Literature research on the regulatory requirementsfor clinical trials and their changes in China, as well as survey on the status quo of the industry, were conducted toprovide reference suggestions for the subsequent improvement of the regulatory system of drug clinical trials andchange management during clinical trials in China. Results and Conclusion: The reform of drug evaluation andapproval in China has been continuously improved in recent years, and there are demands for “cross-border” andchanges in sponsors and production sites along with the development of the industry. Considering the practicalneeds of innovative development and current regulations, under controllable risk conditions, China has a certainfoundation to support the "cross-border" and "cross-border changes" of sponsors and clinical trial drug productionsites. |
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