支持三类新药,创新药临床试验审评审批增设30日通道

大洋网
Sep 15, 2025

国家药监局日前发布并实施《关于优化创新药临床试验审评审批有关事项的公告》(下称“公告”),对符合要求的创新药临床试验申请,在药物临床试验60日默示许可基础上增设创新药临床试验审评审批30日通道。据悉,药物临床试验是药物研发的关键环节,也是确保新药安全性和有效性而开展的科学研究。所以,药品审评审批改革需要兼顾创新药高质量发展和高水平安全。自2019年起,我国药品审评审批制度实施60日默示许可。...

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