文章摘要
于冰,吴正宇,陈江鹏,陈园,王方敏.药物临床研究阶段申办者和生产场地变更研究三:美国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):508-515
药物临床研究阶段申办者和生产场地变更研究三:美国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 Ⅲ on the Changes of Sponsors and Production Sites during theClinical Research Phase of Drugs: The Enlightenment of the Requirements forDrug Clinical Trials and Change Management during Clinical Trials in theUnited States on Improving China's Regulatory System
投稿时间:2023-12-11  
DOI:10.16153/j.1002-7777.2024.05.003
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)
作者单位
于冰 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 
吴正宇 诺和诺德(上海)医药贸易有限公司上海 200131 
陈江鹏 沈阳药科大学亦弘商学院北京 100055 
陈园 沈阳药科大学亦弘商学院北京 100055 
王方敏 上海市药品和医疗器械不良反应监测中心上海 200040 
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中文摘要:
      目的:研究美国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:对美国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:美国药物临床试验监管体系采用审批及检查相结合的方式,通过强化申办者负责制,在风险可控的前提下允许申办者及生产场地在不同国家(跨境)的情况存在。我国近年来药品审评审批改革不断深化,在临床研究期间的变更监管体系已初步建立,未来可分阶段细化我国临床试验期间变更的相关要求,以支持产业发展。
英文摘要:
      Objective: To study the regulatory requirements and implementation of the change managementduring the clinical research of drugs in the United States, and compare it with the current construction andimplementation status 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 ofdrugs in China. Methods: A systematic review and study of regulatory regulations on the change of sponsors andproduction sites during the clinical research in the United States was conducted. Suggestions were provided basedon the current situation of change management during the clinical research in China. Results and Conclusion:The regulatory system for drug clinical trials in the United States adopts a combination of approval and inspection,and allows sponsors and production sites to exist in different countries (cross-border) under the premise ofcontrollable risks by strengthening the sponsor responsibility system. In recent years, China's drug review andapproval reform has been continuously deepening, and a regulatory system for changes during clinical trials hasbeen initially established. In the future, the relevant requirements for changes during clinical trials in China can berefi ned in stages to support industrial development.
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