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1. In accordance with the Measures for the Administration of Drug Registration, written supplementary information shall be returned within 80 days and will not be approved if it is not submitted as required.
. If there are substantial deficiencies in the supplementary information, the Centre will not approve the processing and will not make a second supplement.
. The applicant may voluntarily withdraw the application and re-report it after perfecting the relevant research on his own.
On May 14 this year, the State Drug Administration issued the Notice of the State Drug Administration on the Implementation of the Evaluation of the Conformity of The Quality and Efficacy of Chemical Injection Imitations, which requires consistent evaluation of the varieties that have been listed as chemical injection generics and are not approved in accordance with the principle of consistency with the quality and efficacy of the original drug.
the relevant requirements, and in accordance with the Bulletin on Matters Related to the Evaluation of the Quality and Efficacy of Generic Drugs (No. 100 of 2017), the review shall be completed within 120 days of acceptance.
if the applicant is considered to be required to provide additional information, the applicant shall complete the supplementary information once within 4 months.
time limit for the issue of supplements does not count to the time limit for review.
the original title: CDE: Injection consistency evaluation supplementary information is substantially flawed, according to the non-approval processing! No more secondary supplements!