新药临床试验期间药物警戒和风险控制研究三:药物临床试验期间个例安全性报告监管要求研究

Research Ⅲ on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: On Regulatory Requirements for Individual Case Safety Reports in Clinical Trials of Drugs

目的:通过比较分析国内外关于临床试验期间个例安全性报告的相关法规和指导原则要求的异同点,为加强我国药物警戒监管体系中个例安全性报告的监管要求提供理论依据。方法:通过分析ICH、美国及欧盟临床试验期间个例安全性报告相关的法规以及指导原则情况,与我国相应的监管要求进行比较,研究各国家/地区对试验用药物临床试验期间个例安全性报告监管要求的差异。结果与结论:与其他国家、组织相比,我国已初步建立了临床试验中个例安全性报告快速报告的制度和工作程序,相应的指导原则内容全面,基本涵盖了国际指导原则的核心技术要求,其中基本原则要求一致,但操作细节方面尚缺少详细的指导意见。

Objective: By comparing and analyzing the similarities and differences between domestic and foreign regulations and guidelines on individual case safety reports during clinical trials, this research is to provide theoretical references for strengthening the regulatory requirements for individual case safety reports in China’s pharmacovigilance regulatory system. Methods: The regulations and guildlines for individual case safety reports during clinical trials in ICH, the United States and European Union were analyzed and compared with the relevant regulatory requirements in China. The dif ferences of regulatory requirements for individual case safety reports in various countries/regions during clinical trials of investigational drugs were studied. Results and Conclusion:Compared with other countries and organizations, our country has preliminarily established the regulations of rapid reporting of individual case safety reports during clinical trials and the working procedures. The corresponding guiding principles are comprehensive in content and basically meet the core technical requirements of the international guidlines, of which the basic principles and core technical requirements are consistent, but there is still a lack of detailed guidlines in terms of specifi c operations.