药品不良反应报告和监测工作在及早发现药品新的或严重不良反应和不良事件,避免伤害事件重复发生和蔓延等方面具有重要作用。根据2001年修订的《中华人民共和国药品管理法》第七十一条规定“国家实行药品不良反应报告制度”的要求,2004年3月卫生部和国家食品药品监督管理局联合颁布实施《药品不良反应报告和监测管理办法》(以下简称《办法》),奠定了我国药品不良反应报告 Adverse drug reaction reporting and monitoring work plays an important role in early detection of new or serious adverse drug reactions and adverse events, and in avoiding the recurrence and spread of injuries. According to the “Drug Administration Law of the People’s Republic of China” stipulated in Article 71 of the “Regulations of the People’s Republic of China on Drug Adverse Drug Reactions” in 2001, the Ministry of Health and the State Food and Drug Administration jointly promulgated the “ Adverse Drug Reaction Reporting and Monitoring Management Measures ”(hereinafter referred to as the“ Measures ”), which laid the foundation for reporting adverse drug reactions in China