Alber.F - CMDE“临床评价资料立卷审查要求及常见问题”笔记 的评论
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link: https://www.alberf.cn/archives/314.html
description: 审查机构临床和生物统计一部审查范围首次注册延续注册（必要时）复杂许可事项变更（必要）临床试验审批一票否决场景没有提交临床评价资料，一票否决注册，不对其它内容提问题；常见问题境外企业仅提交中文临床...
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