文章摘要
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 Change of Applicants 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 stage in China
投稿时间：2023-12-11  修订日期：2024-04-16
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
杨建红 国家药品监督管理局药品审评中心 
夏雨 扬子江药业集团上海海路生物技术有限公司 
李圆圆 再鼎医药（上海）有限公司 
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 
高丽萍 沈阳药科大学亦弘商学院 
张元媛 中国药品监督管理研究会 
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的梳理和行业现状的调研,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,但在临床试验的监管要求与ICH主要国家/地区仍有差异,且行业存在申办者及生产产地变更的需求。通过已有法规的梳理及我国药物研发现状的调研,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: To provide reference for improving the regulatory system of drug clinical trials and change management during clinical trials by reviewing the regulatory requirements for drug clinical trials and change management during clinical trials 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 research on the current situation 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, but there are still differences in the regulatory requirements for clinical trials between China and major countries/regions of the International Conference on Harmonization (ICH), and there is a demand for changes in sponsorship and production sites in the industry.Through the review of existing regulations and the investigation of the current situation of drug research and development in China, it is of great reference value for further improving the regulatory system of drug clinical trials and change management during clinical trials in China.
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