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 the Clinical Research Phase of Drugs:Research and Analysis on the Current Situation of Sponsor and Production Site Changes in the Clinical Research Phase in China
于冰 1杨建红 2夏雨 3李圆圆 4顾瑶华 5芦臣书 6高丽萍 7张元媛 8王方敏9
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. 国家药品监督管理局药品审评中心,北京 100076
- 3. 扬子江药业集团上海海路生物技术有限公司,上海 201203
- 4. 再鼎医药(上海)有限公司,北京 100022
- 5. 苏州工业园区药品管理中心,苏州 215127
- 6. 百济神州(北京)生物科技有限公司,北京 100022
- 7. 沈阳药科大学亦弘商学院,北京 100055
- 8. 中国药品监督管理研究会,北京 100082
- 9. 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: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".
Abstract
Objective:To provide reference for improving the regulatory system of drug clinical trials and change management during clinical trials by reviewing the corresponding regulatory requirements in China and investigating the current situation of the industry.Methods:Literature research on the regulatory requirements for clinical trials and their changes in China,as well as survey on the status quo of the industry,were conducted to provide reference suggestions for the subsequent improvement of the regulatory system of drug clinical trials and change management during clinical trials in China.Results and Conclusion:The reform of drug evaluation and approval in China has been continuously improved in recent years,and there are demands for"cross-border"and changes in sponsors and production sites along with the development of the industry.Considering the practical needs of innovative development and current regulations,under controllable risk conditions,China has a certain foundation to support the"cross-border"and"cross-border changes"of sponsors and clinical trial drug production sites.
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