新药临床试验期间药物警戒和风险控制研究六:完善新药临床试验期间药物警戒和风险控制监管体系的建议

Research Ⅵ on Pharmacovigilance and Risk Control During Clinical Trials of New Drugs: Suggestions for Improving the Supervision System of Pharmacovigilance and Risk Control During Clinical Trail of New Drugs

目的:为完善我国新药临床试验期间药物警戒和风险控制监管体系提供参考。方法:基于本课题组组织开展的“新药临床试验期间药物警戒和风险控制研究”课题研究,在本栏目相关论文对欧美等国家药物警戒监管体系的深入研究,对国内外药物警戒法规和指导原则等的对比分析,以及结合对问卷调查结果进行综合分析的基础上,提出完善我国新药临床试验期间药物警戒和风险控制监管体系的研究建议。结果与结论:从监管体系和关键要素两个方面,提出了完善我国新药临床试验期间药物警戒和风险控制监管体系的建议,包括完善监管机构人员培训、政策法规宣贯、引进专业人才、共享监管信息,以及强化临床试验期间临床试验方案、研究者手册、知情同意、非预期严重不良反应和研发期间安全性更新报告、研发期间安全性更新报告审核和反馈、不良反应事件报告、风险控制计划等药物警戒关键要素管理等。

Objective: To provide references for improving the supervision system of pharmacovigilance and risk control during clinical trials of new drugs in China. Methods: Based on the research project of "Research on Pharmacovigilance and Risk Control during Clinical Trials of New Drugs" organized by our research group,on the basis of papers including in-depth research on the pharmacovigilance regulatory system of Europe and the United States, the comparative analysis of domestic and foreign pharmacovigilance regulations and guiding principles, and the comprehensive analysis combined with the questionnaire survey results, suggestions on improving the regulatory system of pharmacovigilance and risk control during new drug clinical trials in China were put forward. Results and Conclusion: From the perspective of the supervision system and key elements,some suggestions were made to improve the supervision system of pharmacovigilance and risk control during the clinical trial of new drugs in China, including improving the personnel training of regulatory system, publicizing and implementing relevant policies and regulations, introducing professionals, sharing regulatory information,and strengthen the management of key pharmacovigilance elements such as clinical trial protocol, investigator’s brochure, informed consent, suspected unexpected serious adverse reaction(SUSAR) and development safety update report(DSUR), review and feedback of DSUR, adverse reaction event report, risk control plan(RCP), etc.