文章摘要
药物临床研究阶段申办者和生产场地变更研究二： 欧盟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 Ⅱ on the Change of Applicants and Production Sites during the Clinical Research Phase of Drugs: The Enlightenment of the European Union's Requirements for Drug Clinical Trial and Change Management During Clinical Trial on Improving China's Regulatory System
投稿时间：2023-12-11  修订日期：2024-04-24
DOI：
中文关键词: 临床试验  临床试验期间  变更管理  申办者变更  生产场地变更
英文关键词: clinical trial  clinical trial period  change management  sponsor change  production site change
基金项目:
作者单位邮编
王宏扬 阿斯利康全球研发中国中心 100176
陈江鹏 沈阳药科大学亦弘商学院 
顾瑶华 苏州工业园区药品管理中心 
芦臣书 百济神州（北京）生物科技有限公司 
夏雨 扬子江药业集团上海海路生物技术有限公司 
连志荣 阿斯利康全球研发中国中心 
吴正宇* 诺和诺德（上海）医药贸易有限公司 200131
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中文摘要:
      目的:通过法规比较研究分析,为完善我国药物临床试验及临床试验期间变更管理,特别是临床试验期间申办者和生产场地及其变更管理提供参考。方法:对欧盟药物临床试验及临床试验期间变更管理的法规监管要求和实施情况、尤其是临床试验期间申办者和生产场地跨境管理和跨境变更的经验进行研究整理,并与我国当前相关监管法规建设和实施现状进行比较分析。结果与讨论:欧盟的临床试验管理体系比较完善成熟,其统一系统流程和批准管理的并行审评程序、申办者及其法定代理人的资质和责任要求、临床研究用药生产场地监管及其变更风险管控等保障下,允许临床试验申办者、生产场地等在临床试验期间发生变更并且不限制该变更是否跨境,对我国有参考价值。
英文摘要:
      Objective: Through comparative research and analysis of regulations, this study aims to provide a reference for improving China"s drug clinical trials and change management during clinical trials, especially for the sponsor, production site, and their change management during clinical trials. Methods: This study collates the regulatory requirements and implementation of the EU"s drug clinical trial and change management during clinical trials, especially the experience of cross-border management and cross-border changes of the sponsor and production site during clinical trials, and compares it with the current regulatory and implementation status of China. Results and Discussion: The clinical trial management system of the EU is relatively mature and complete, with its unified system process and parallel review process for approval management, the qualification and responsibility requirements of the sponsor and its legal agent, the supervision of the clinical research drug production site, and the risk control of change management.? Under these guarantees, the sponsor and production site of clinical trials are allowed to make changes during clinical trials without limiting whether the changes are cross-border, which is of reference value to China.
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