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

ResearchⅡon the Changes of Sponsors and Production Sites during the Clinical Research Phase of Drugs:The Enlightenment of EU Requirements for Drug Clinical Trials and Change Management during Clinical Trials on Improving China's Regulatory System

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变更、生产场地变更及其变更管理提供参考。方法:对欧盟药物临床试验申请及临床试验期间变更管理的法规监管要求和实施情况进行研究整理,与我国当前相关监管法规建设和实施现状进行比较分析并提出建议。结果与结论:欧盟允许临床试验申办者和临床试验药物生产场地分属境内、外的临床试验注册申请及变更申请。欧盟临床试验管理制度相对成熟完善,比如其统一的临床试验申请门户网站及临床试验信息数据库、一体化的科学和伦理双重审查并行的审评程序,对申办者及其法定代理人的资质和责任要求、对临床研究用药品生产场地及其变更的监管和风险控制等监管措施,对我国有参考价值。

Objective:To provide reference through comparative research and analysis of regulations,for improving China's drug clinical trials and change management during clinical trials,especially for the sponsor change or production site change,and their change management during clinical trials.Methods:The regulatory requirements and implementation of European Union(EU)drug clinical trial applications and change management during clinical trials were collected and studied.Suggestions were provided by comparing them with the present regulatory framework and situation of China.Results and Conclusion:In EU,the clinical trial sponsors and clinical trial drug production sites are allowed to apply for registration and change of clinical trials both domestically and internationally.The EU clinical trial regulatory system is relatively mature and complete which are of reference value to China,such as a unifi ed clinical trial application portal website and clinical trial information database,an integrated system of scientifi c and ethical in parallel review procedures,the qualifi cation and responsibility for the sponsors and their legally designated representatives,and measures of supervision and risk control for production sites of investigational drugs as well as their changes.