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Notice of the Center for Drug Review of the State Food and Drug Administration on the issuance of the "Work Procedures for Changes during the Review of Drug Registration Applications (Trial)" (Drug Review Industry [2022] No.
597)
597)
Release date: 20221111
In order to cooperate with the implementation of the Measures for the Administration of Drug Registration, further standardize the changes during the review of drug registration applications, and ensure the safety, effectiveness and quality control of drugs, the Center for Drug Review has organized and formulated the "Working Procedures for Changes during the Review of Drug Registration Applications (Trial)" (see Annex), which is hereby issued after the review and consent of the State Medical Products Administration and will be implemented
from the date of promulgation.
Annex: Changes to the Working Procedures During the Review of Drug Registration Applications (Trial)
Drug Review Center, State Food and Drug Administration
November 9, 2022