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 the Clinical Research Phase of Drugs:The Enlightenment of the Requirements for Drug Clinical Trials and Change Management during Clinical Trials in the United States on Improving China's Reg
于冰 1吴正宇 2陈江鹏 3陈园 3王方敏4
作者信息
- 1. 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
- 2. 诺和诺德(上海)医药贸易有限公司,上海 200131
- 3. 沈阳药科大学亦弘商学院,北京 100055
- 4. 上海市药品和医疗器械不良反应监测中心,上海 200040
- 折叠
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.
Abstract
Objective:To study the regulatory requirements and implementation of the change management during the clinical research of drugs in the United States,and compare it with the current construction and implementation 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 of drugs in China.Methods:A systematic review and study of regulatory regulations on the change of sponsors and production sites during the clinical research in the United States was conducted.Suggestions were provided based on 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 of controllable risks by strengthening the sponsor responsibility system.In recent years,China's drug review and approval reform has been continuously deepening,and a regulatory system for changes during clinical trials has been initially established.In the future,the relevant requirements for changes during clinical trials in China can be refined in stages to support industrial development.
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Key words
clinical trial/change management/sponsor change/production site change/drug registration引用本文复制引用
基金项目
我国临床研究阶段申办者和生产场地变更研究课题(2021-Y-Y-22)
出版年
2024
NETL
NSTL
万方数据