Generic drugs are drugs with the same active ingredients, dosage forms, routes of administration and therapeutic effects as the original drugs. The consistency evaluation of quality and efficacy means that the approved generic drugs can be consistent with the original drugs in quality and efficacy, and can be replaced by the original drugs in clinic, which is conducive to saving social medical expenses.
In the National Catalogue of Essential Drugs (Version 20 12), consistency evaluation should be completed before the end of June 10, 2007 for generic oral solid preparations. For other generic drugs approved for listing before the implementation of the new registration classification of chemical drugs, after the first variety has passed the consistency evaluation, the consistency evaluation of the same variety of other pharmaceutical manufacturers should be completed within 3 years in principle; If it is not completed within the time limit, it will not be registered again.