食品药品监管局要求做好中药注射剂安全性再评价
发布时间:2011-04-18
来源:食品药品监管局网站
为做好中药注射剂安全性再评价工作,2011年,国家食品药品监督管理局将全面开展中药注射剂标准提高,分批对中药注射剂开展评价性抽验工作,加强对中药注射剂品种的不良反应监测,并对重点品种组织开展综合评价。为做好相关工作,日前,国家食品药品监督管理局就有关事宜发出通知。
通知要求,各省(区、市)药品监管部门要继续组织辖区内中药注射剂生产企业做好生产及质量控制环节的风险排查,切实控制中药注射剂产品安全风险。要做好相关品种的综合评价工作,指导生产企业开展中药注射剂安全性再评价相关研究,将安全风险评估作为日常监管工作长期开展。
各级食品药品监督管理部门应注重发挥综合监管效能,将风险排查与日常监督检查紧密结合,将安全风险评估与质量标准提高及药品抽验工作紧密结合,不断提高中药注射剂质量和安全水平,保证公众用药安全。
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