文章摘要
于冰,杨建红,夏雨,李圆圆,顾瑶华,芦臣书,高丽萍,张元媛,王方敏.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[J].中国药事,2024,38(5):516-525
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 theClinical Research Phase of Drugs: Research and Analysis on the CurrentSituation of Sponsor and Production Site Changes in the Clinical ResearchPhase in China
投稿时间:2023-12-11  
DOI:10.16153/j.1002-7777.2024.05.004
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 
杨建红 国家药品监督管理局药品审评中心北京 100076 
夏雨 扬子江药业集团上海海路生物技术有限公司上海 201203 
李圆圆 再鼎医药(上海)有限公司北京 100022 
顾瑶华 苏州工业园区药品管理中心苏州 215127 
芦臣书 百济神州(北京)生物科技有限公司北京 100022 
高丽萍 沈阳药科大学亦弘商学院北京 100055 
张元媛 中国药品监督管理研究会北京 100082 
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: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”。
英文摘要:
      Objective: To provide reference for improving the regulatory system of drug clinical trials andchange management during clinical trials by reviewing the corresponding regulatory requirements in China andinvestigating the current situation of the industry. Methods: Literature research on the regulatory requirementsfor clinical trials and their changes in China, as well as survey on the status quo of the industry, were conducted toprovide reference suggestions for the subsequent improvement of the regulatory system of drug clinical trials andchange management during clinical trials in China. Results and Conclusion: The reform of drug evaluation andapproval in China has been continuously improved in recent years, and there are demands for “cross-border” andchanges in sponsors and production sites along with the development of the industry. Considering the practicalneeds of innovative development and current regulations, under controllable risk conditions, China has a certainfoundation to support the "cross-border" and "cross-border changes" of sponsors and clinical trial drug productionsites.
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