文章摘要
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 Change of Applicants and Production Sites during the Clinical Research Phase of Drugs：The Enlightenment of the Requirements for Drug clinical Trial and Management of Changes during Clinical Trial in the United States on Improving China's Regulatory System
投稿时间：2023-12-11  修订日期：2024-04-25
DOI：
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:
作者单位邮编
于冰 中国外商投资企业协会药品研制和开发工作委员会 100020
吴正宇 诺和诺德（上海）医药贸易有限公司 
陈江鹏 沈阳药科大学亦弘商学院 
陈园 沈阳药科大学亦弘商学院 
王方敏* 上海市药品和医疗器械不良反应监测中心 200040
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中文摘要:
      目的:通过对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的研究分析,结合与我国当前相关监管法规建设和实施现状的比较,为完善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和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可借鉴的启示建议。结果与结论:我国近年来药品审评审批改革不断深化,但与ICH主要国家/地区仍有差异。在临床研究期间申办者和生产场地变更的监管要求方面,美国药物临床试验及临床试验的社会共治体系及其临床试验期间的监管(包括变更)体系,对进一步完善我国临床试验及临床试验期间变更的监管体系具有参考价值。
英文摘要:
      Objective: Through the research and analysis of the regulatory requirements and implementation of the change management during the clinical research of drugs in the United States, combined with the comparison with the current construction and implementation status of relevant regulatory regulations in China, this study provides a reference for improving the regulatory system of the change management during the clinical research of drugs. Methods: Systematically combing and studying the regulations and supervision of the change of sponsor and production site during the clinical research in the United States, and combining with the current situation of change management during the clinical research in China, this study proposes enlightening suggestions that can be used for reference. Results and Conclusion: In recent years, the reform of drug evaluation and approval in China has been continuously deepened, but there are still differences with the main countries/regions of ICH. In terms of the regulatory requirements for the change of sponsor and production site during the clinical research, the social co-governance system of drug clinical trials and clinical trials in the United States, as well as its regulatory (including change) system during the clinical trials, have reference value for further improving the regulatory system of clinical trials and change during the clinical trials in China.
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