On December 28, the official website of the State Food and Drug Administration issued the "Announcement on Matters Related to the Evaluation of the Quality and Efficacy Consistency of Generic Drugs (2018 No. 102)" of the State Drug Administration, and the "Conformance on the Quality and Efficacy of Generic Drugs". Policy Interpretation of the Announcement on Evaluation of Related Matters.

 

Consistency evaluation is limited on December 31, canceled!

 

Regarding the time limit requirements for consistency evaluation, the State Administration of Food and Drug Administration clearly stated that "time is subject to quality and reasonable adjustment of relevant work time limits and requirements":

 

“Generic drugs including essential drug varieties approved for marketing before the implementation of the new registration classification of chemical drugs, since the first variety has passed the consistency evaluation, in principle, the same varieties of other drug manufacturers should complete the consistency evaluation within 3 years. If it is not completed, the enterprise may submit an application for deferred evaluation to the local provincial drug regulatory department after evaluation and it is deemed to be clinically necessary and the market is short of varieties. After the provincial drug regulatory department and the health administrative department have organized a study and determined it may be extended appropriately. If it is not completed within the time limit, it will not be re-registered."