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国家药监局:全面推进药品上市许可持有人制度试点

健康 来源:央视网 2018年12月25日 10:18 A-A+ 二维码
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原标题:

央视网消息:记者从近日在四川举办的“2018中国医药高质量发展研讨会”上了解到,明年我国将全面推进药品上市许可持有人制度试点。在药品监管方面,建立监管云数据,深度应用新型信息化监管方式。 

我国药品审评审批制度改革三年多来,排队等待审评的注册申请已由2015年9月高峰时的近22000件降至4000件,防治艾滋病、恶性肿瘤、重大传染病和罕见病等疾病的创新药,以及儿童用药、老年人特有和多发疾病用药等17种药品都列入了优先审评审批范围。据了解,现在我国的药品审评标准、质量和效率都有很大提高。

同时,药品上市许可持有人制度在十个试点省市推开,共提出药品申请1118件,明年这一制度将在全国全面推进,并推进部门间信息共享应用,加强事中事后监管。

国家药监局副局长颜江瑛介绍,目前我国正在着手制定相关的规划,围绕数据化,信息化,智能化的目标,整合应用数据共享,数据资源,加快推进监管、互联网加政务服务,互联网加监管等重点项目建设。

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BlobNotFoundThe specified blob does not exist. RequestId:8339a903-201e-0099-0a7a-12b7ab000000 Time:2019-05-24T21:49:52.1243717Z 药监局 | 药品上市许可
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我要纠错编辑:邹杨 责任编辑:张福伟
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