The State Council on March 5 decided to launch a consistency evaluation for the quality and curative effect of generic drugs, which is expected to stimulate the upgrade and structural adjustment of the pharmaceutical industry.
The policy applies to all generic drugs that have not been approved according to consistency evaluation for the quality and curative effect of the brand-name drugs before the implementation of the new registry classification of chemical drugs.
All oral solid preparations of generic drugs on the National Essential Drugs List (2012) approved before Oct 1 2007 should be evaluated by the end of 2018. Under special circumstances such as necessary clinical trials, the deadline can be postponed to the end of 2021.
The State Council urged related departments to guide pharmaceutical enterprises to participate in the evaluation.