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药监局审评中心1月24日说明,个别仿制药的一致性研究数据重复,是其做信息公开时编辑错误,已经更正。 (国家药品监督管理局药品审评中心,图:AirMovingDevice)
医保和药监局通报赴上海调研集采仿制药质量风险问题的情况。
“氨氯地平血压不降”是个人用药体验。瑞金医院已发表真实世界研究成果,认可药效和安全性。
麻醉药丙泊酚,瑞金医院2024年使用记录,诱导期仿制药人均用量略有增加,但全过程总用量没有统计学差异,未发现“麻药不睡”。
今后将进一步督促集采中选药企主动公开药品质量数据。支持权威医疗机构对原研药和过评仿制药开展真实世界研究,考察疗效,提示监管重点。
国家医保局路透社
药监局审评中心1月24日下架了其公示的仿制药一致性研究数据,后在春节期间重新编辑发布,修正了其中数值不自洽明显有误的条目。



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医保和药监局通报赴上海调研集采仿制药质量风险问题的情况。
“氨氯地平血压不降”是个人用药体验。瑞金医院已发表真实世界研究成果,认可药效和安全性。
麻醉药丙泊酚,瑞金医院2024年使用记录,诱导期仿制药人均用量略有增加,但全过程总用量没有统计学差异,未发现“麻药不睡”。
今后将进一步督促集采中选药企主动公开药品质量数据。支持权威医疗机构对原研药和过评仿制药开展真实世界研究,考察疗效,提示监管重点。
国家医保局路透社
药监局审评中心1月24日下架了其公示的仿制药一致性研究数据,后在春节期间重新编辑发布,修正了其中数值不自洽明显有误的条目。

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