近期,NMPA发布《优化创新药临床试验审评审批有关事项(征求意见稿)》,提出将创新药临床试验默示许可的审评时限由60日压缩至30日。制度加码、监管提速,一场围绕创新药审批逻辑的“结构性变革”正在悄然发生。01从60天到30天,这场改革改了什么?“30天”不是简单的时间砍半,而是新药临床试验申请审评制度的一次系统性升级。6月13日,为落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业...
Source Link近期,NMPA发布《优化创新药临床试验审评审批有关事项(征求意见稿)》,提出将创新药临床试验默示许可的审评时限由60日压缩至30日。制度加码、监管提速,一场围绕创新药审批逻辑的“结构性变革”正在悄然发生。01从60天到30天,这场改革改了什么?“30天”不是简单的时间砍半,而是新药临床试验申请审评制度的一次系统性升级。6月13日,为落实《国务院办公厅关于全面深化药品医疗器械监管改革促进医药产业...
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