ICS11.020 CCSC00 2025-02-26发布 2025-03-04实施 苏州市市场监督管理局发布DB3205 药械妆不良反应（事件）监测哨点 工作指南 Guidelinesformonitoringsentinelsofadversereactions(events)of drugs,medicaldevices,andcosmetics苏州市地方标准 DB3205/T1175—2025 DB3205/T1175—2025 I目次 前言..................................................................................II 1范围................................................................................1 2规范性引用文件......................................................................1 3术语和定义..........................................................................1 4总则................................................................................1 5机构设置............................................................................1 5.1监测工作领导小组..............................................................1 5.2监测工作责任科室..............................................................2 6人员配置............................................................................2 6.1人员配备......................................................................2 6.2人员要求......................................................................2 7设施设备............................................................................2 8制度和程序..........................................................................3 9日常监测............................................................................3 9.1收集与记录....................................................................3 9.2报告核实......................................................................3 9.3分析与评价....................................................................3 9.4报告提交......................................................................4 9.5随访与调查....................................................................4 10风险发现与控制.....................................................................4 10.1风险发现.....................................................................5 10.2风险控制.....................................................................5 11宣传与培训.........................................................................5 11.1宣传工作.....................................................................5 11.2培训工作.....................................................................5 12研究与合作.........................................................................5 13数据管理...........................................................................6 附录A（规范性）药品不良反应报告表....................................................7 附录B（规范性）药品群体不良事件基本信息表............................................9 附录C（规范性）使用单位医疗器械不良事件报告表.......................................10 附录D（规范性）化妆品不良反应报告表.................................................11 参考文献..............................................................................14