文章摘要
吴正宇,连志荣,王宏扬,李圆圆,张小勇,杨建红.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[J].中国药事,2024,38(5):491-498
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 Changes of Sponsors and Production Sites during the ClinicalResearch Phase of Drugs: The Enlightenment of Japanese Requirementsfor Drug Clinical Trials and Change Management during Clinical Trials onImproving China's Regulatory Sy
投稿时间:2023-12-11  
DOI:10.16153/j.1002-7777.2024.05.001
中文关键词: 临床试验  变更管理  申办者变更  生产场地变更  药品监管
英文关键词: clinical trial  change management  sponsor change  production site change  drug administration
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)
作者单位
吴正宇 诺和诺德(上海)医药贸易有限公司上海 200131 
连志荣 阿斯利康全球研发中国中心北京 100176 
王宏扬 阿斯利康全球研发中国中心北京 100176 
李圆圆 再鼎医药(上海)有限公司北京 100022 
张小勇 沈阳药科大学亦弘商学院北京 100055 
杨建红 国家药品监督管理局药品审评中心北京 100076 
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中文摘要:
      目的:研究日本药物临床研究期间变更管理的法规监管要求和实施情况,并与我国当前相关监管法规建设和实施现状进行比较,为完善我国药物临床研究期间申办者和生产场地变更管理的监管体系提供参考。方法:对日本临床研究期间申办者和生产场地变更的监管法规进行系统的梳理研究,结合我国临床研究期间变更管理情况提出建议。结果与结论:日本允许临床试验申办者和临床试验药物生产场地分属境内、外的临床试验注册申请及变更申请。日本监管体系中“履职承责的境内代理人制度、全面高效的咨询服务、全程全球的监管检查”等监管措施,对我国有参考价值。
英文摘要:
      Objective:To study the regulatory requirements and implementation of the change managementduring the clinical research of drugs in Japan, and compare it with the current construction and implementationstatus of relevant regulatory regulations in China, in order to provide reference for improving the regulatory system of the change management of sponsors and production sites during the clinical research of drugs in China.Methods: A systematic review and study of regulatory regulations on the change of sponsors and production sitesduring the clinical research in Japan was conducted. Suggestions were provided based on the current situation ofchange management during the clinical research in China. Results and Conclusion: In Japan, the clinical trialsponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trialsboth domestically and internationally. The regulatory measures in the Japanese regulatory system are of referencevalue to China, such as "domestic agent system for fulfi lling responsibilities and obligations, comprehensive andeffi cient advisory services, and worldwide regulatory inspections covering the whole process".
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