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黄金城hjc999

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公司新闻

行业动态

2022

中华人民共和国药品管理法（2019版）培训

　　中华人民共和国药品管理法(2019版)，由中华人民共和国第十三届全国人民代表大会常务委员会第十二次会议于2019年8月26日修订通过，于2019年12月1日起施行。

　　一直以来，黄金城hjc999积极关注，认真学习，并在12月14日上午，由公司质量副总经理王静王总在行政楼三楼会议室，对公司全体中高层管理人员及生产、技术、设备、采购、办公室、质量部人员进行了中华人民共和国药品管理法(2019版)的培训。

　　王总分别从其修订背景、指导思想、法律结构调整和特点、药品上市许可持有人制度、章节名称的修改和条款变化、药品相关环节的制度改革和条款修改、法律责任部分的修改几项内容进行了讲解与宣贯。其中着重解读了主体责任、全程管控、科学监管的指导思想;主体创新的药品上市许可持有人制度;药品上市许可持有人全过程的法律责任;条款的变化;追溯标准---追溯体系---互联互通---数据价值的药品追溯制度;药物警戒制度;安全性、有效性和质量可控性、质量管理、风险防控的原辅包关联审评审批制度;对法律责任进行了着重讲解。

　　最后，王总就我公司与新法接轨的药品上市许可持有人制度、药品追溯制度、药物警戒制度、供应商审计管理规程、质量保证责任条款、年度报告制度、包装标签修订、药品购销记录，包括药品上市后的风险管理计划、运输协议中的质量保证等相关工作对责任部门进行了详细的要求与部署分工。

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这里是占位文字

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