国家药管局药品注册管理司司长王平:罕见病治疗药品3个月内完成审结

2019-03-24 佚名 医谷综合报道

今日(3月23日),国家药品监督管理局药品注册管理司司长王平出席国务院发展研究中心在北京主办的“中国发展高层论坛2019年会”,并在“拨开用药难迷雾”分会场上发表演讲。

今日(3月23日),国家药品监督管理局药品注册管理司司长王平出席国务院发展研究中心在北京主办的“中国发展高层论坛2019年会”,并在“拨开用药难迷雾”分会场上发表演讲。

王平表示,近年来在社会各界同仁的共同努力下,国家药监局按照中央的统一部署和要求,采取了一系列的举措,深化审评审批制度改革,努力营造鼓励创新的良好氛围,力争让国内外的新药好药,能够在最短的时间内汇集到国内的病患者手中。

王平同时表示,国家药监局已对临床急需的境外新药建立专门的审评机制,遴选第一批临床急需的48个品种,包括罕见病的治疗药品和治疗严重危及生命的部分药品,对于罕见病治疗药品的审批时间是3个月内审结,对于其他的急需的治疗药品是6个月内审结。

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    2019-03-26 syscxl
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    2019-03-26 zhyy93