同步解读 专业精准

同步解读 专业精准

2024年上半年审结转出注册项目审评用时情况

发布时间:2024年08月26日

20241-6月审结转出注册项目审评用时情况


Review time of submissions for registration completed and transferred in January to June 2024


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备注:


1.本表涉及时间均为工作日。

The time in this table is working days.


2.补正资料平均用时=补正资料总用时/相关项目审结转出总数量

average time of deficiency response = total time of deficiency response /total number of completed and transferred submissions with deficiencies. 


3.总用时=审评平均用时+专家咨询平均用时+补正资料平均用时

Total time = average review time+ average time of expert consultation + average time of deficiency response.


4.第二和第三类产品平均用时=第二类和第三类产品用时/第二类和第三类产品总数量

Average time for Class II and III products = total treview time of class II and III products/the total number of class II and III product submissions.


5.应急审评用时不在统计范围内

Time of emergency review is out of the scope of this statistics.



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