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Review Time Of Submissions For Registration Completed And Transferred In January To June 2024

2024-09-11

Submission type Product classification Average review time (days) Average time of expert consultation (days) Average time of deficiency response (days) Total time (days)
Product registration Class Il 75 1 236 312
Class III 98 1 175 274
Class Il and III 96 1 181 279
Change of registration Class Il 47 0 68 115
Class Ill 71 0 67 139
Class Il and III 65 0 67 132
Renewal of registration Class II 21 0 3 24
Class Ill 24 0 3 27
Class Il and III 23 0 3 26

Remarks:

1.The time in this table is working days.

2.Average time of deficiency response = Total time of deficiency response /Total number of completed and transferred submissions with deficiencies.

3.Total time = Average review time+ Average time of expert consultation + Average time of deficiency response.

4.Average time for Class II and III products = Total review time of class II and III products/The total number of class II and III product submissions.

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