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| 药物临床研究阶段申办者和生产场地变更研究一： 日本药物临床试验及临床试验期间变更管理要求对我国完善监管体系的启示 |
| Research Ⅰ on the Change of Applicants and Production Sites during the Clinical Research Phase of Drugs：The Enlightenment of Japanese Drug Clinical Trials and Change Management Requirements during Clinical Trials on Improving China's Regulatory System |
| 投稿时间：2023-12-11 修订日期：2024-04-25 |
| DOI： |
| 中文关键词: 临床试验 临床试验期间 变更管理 申办者变更 生产场地变更 |
| 英文关键词: clinical trial clinical trial period change management sponsor change production site change |
| 基金项目: |
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| 中文摘要: |
| 目的:通过法规比较研究分析,为完善我国药物临床试验及临床试验期间变更管理,特别是临床试验期间申办者和生产场地及其变更管理提供参考。方法:对日本药物临床试验及临床试验期间变更管理的法规监管要求和实施情况的进行研究整理,并与我国当前相关监管法规建设和实施现状进行比较分析。结果与结论:日本药物临床试验期间允许申办者和临床试验药物生产场地跨境及跨境变更。日本监管体系中“建立履职承责的境内代理人制度、全面高效的咨询服务、全程全境的监管检查”等监管措施,对我国有参考价值。 |
| 英文摘要: |
| Objective: Through comparative research and analysis of regulations, this study aims to provide reference for improving China's drug clinical trials and change management during clinical trials, especially for the sponsor, production site, and change management during clinical trials. Methods: This study collates the regulatory requirements and implementation of Japan's drug clinical trials and change management during clinical trials, and compares them with the current regulatory and implementation status of China. Results and Conclusion: Japan allows sponsors and clinical trial drug production sites to make cross-border and cross-border changes during drug clinical trials.Japan's regulatory system has regulatory measures such as "establishing a domestic agent system for fulfilling duties and responsibilities, comprehensive and efficient advisory services, and full-process and full-boundary regulatory inspections", which are of reference value to China. |
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