ICS0312010 CCSC00 团 体 标 准 T/SHSPTA009—2025 境外药品上市许可持有人指定境内责任人 质量管理导则 2025-09-03发Directive for quality management of designated domestic responsible persons by overseas drug marketing authorization holders 布 2025-09-10实施 上海医药商业行业协会  发布 全国团体标准信息平台 全国团体标准信息平台 T/SHSPTA009—2025 I目次 前言.................................................................................III 引言..................................................................................IV 1范围................................................................................1 2规范性引用文件......................................................................1 3术语和定义..........................................................................1 4境外持有人责任......................................................................2 4.1承担药品全生命周期责任..........................................................2 4.2境外持有人对境内责任人的基本管理职责............................................2 5境内责任人条件和要求................................................................2 5.1主体资格........................................................................2 5.2履职能力........................................................................2 5.3质量管理体系....................................................................3 5.4药品上市后质量管理能力..........................................................3 5.5快速响应和应急处置能力..........................................................3 5.6风险防控及责任赔偿能力..........................................................3 5.7境内责任人保障授权的要求........................................................3 6境内责任人报告与变更................................................................3 6.1报告范围........................................................................3 6.2首次进口销售前报告内容..........................................................4 6.3药品信息变更报告内容............................................................4 7境内责任人质量保证体系..............................................................4 7.1药品上市后质量保证体系..........................................................4 7.2质量管理制度....................................................................4 8药品追溯............................................................................6 8.1建立药品追溯系统................................................................6 8.2追溯码赋码......................................................................6 8.3追溯管理........................................................................6 9药品上市后变更和再注册..............................................................7 9.1药品上市后变更..................................................................7 9.2药品再注册......................................................................7 10药物警戒活动.......................................................................7 10.1总体要求.......................................................................7 10.2药物警戒内容...................................................................7 10.3人员管理.......................................................................8 10.4系统维护和更新.................................................................8 10.5药物警戒活动委托...............................................................8 全国团体标准信息平台 T/SHSPTA009—2025 II11药品召回...........................................................................8 11.1建立药品召回制度...............................................................8 11.2召回药品处置...................................................................8 12质量投诉...........................................................................9 12.1建立质量投诉制度...............................................................9 12.2促进药品质量提升...............................................................9 13药品年度报告.......................................................................9 13.1总体要求.......................................................................9 13.2时限要求.......................................................................9 13.3内容要求.......................................................................9 13.4疫苗质量年度报告要求.......................................................