我国药品上市许可持有人药物警戒职责分析  

Pharmacovigilance Duties of Marketing Authorization Holders under of New Drug Administration Law of the People's Republic of China

作　　者：孙骏[1] 王佳域[1] 柳鹏程[2] 于丹丹[1] 王敏娇 沈梦秋 SUN Jun;WANG Jiayu;LIU Pengcheng;YU Dandan;WANG Minjiao;SHEN Mengqiu(Jiangsu Province Drug Adverse Reaction Monitoring Center,Nanjing Jiangsu 210002,China;China Pharmaceutical University,Nanjing Jiangsu 211198,China)

机构地区：[1]江苏省药品不良反应监测中心,江苏南京210002 [2]中国药科大学,江苏南京211198

出　　处：《中国药物警戒》2020年第10期681-687,共7页Chinese Journal of Pharmacovigilance

摘　　要：目的梳理我国法律法规中对药品上市许可持有人开展药物警戒工作的职责要求。方法采用文献归纳法对我国法律法规相关内容进行梳理、归纳、总结。结果我国当前对药品注册申请人及药品上市许可持有人在药物警戒工作方面的主要要求为,建立健全药物警戒体系和开展药品风险的监测、识别、评估、控制等具体活动。结论我国应完善药物警戒法律法规体系,做到上下呼应、前后连续、新旧衔接;配套相关细化指南,实施精准化指导,促使持有人有效开展药物警戒活动;合理设计监管路线,加强监管力度,推动药物警戒制度落到实处。Objective To sort out pharmacovigilance duties of MAH according to the new Drug Administration Law of the People's Republic of China.Methods Use the literature induction method to sort out and summarize the relevant content of legal regulations in China.Results The main pharmacovigilance duties of MAA/MAH for applicants and holders in China are to establish and improve the pharmacovigilance system and carry out specific activities such as monitoring,identification,evaluation and control.Suggestions China should improve the legal system of pharmacovigilance,to link up different laws and regulations,provide detailed guidelines and carry out accurate guidance,urge the MAH to effectively carry out pharmacovigilance activities,and rationally design the route of supervision and control,strengthen supervision and promote the implementation of pharmacovigilance system.

关 键 词：药物警戒 药品管理法 上市许可持有人 法定职责 

分 类 号：R951[医药卫生—药学]