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中国优先审评计划对缩小中外新药准入差距的关键作用
在中国,长期以来,与美国和欧盟相比,新药上市延迟问题较为突出。这一延迟主要由两方面原因造成:一是冗余的审查程序导致审查时间冗长;二是药物申请提交滞后。在中国,新药申请(NDA)的提交前提是进行独立的国内临床试验,而提交后,由于申请积压严重和药品监管机构人员不足,平均需要等待 12.3 ...
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