The State Drug Administration recently announced that 16 more generic drugs have been proven equivalent to their original counterparts in both quality and efficacy, bringing the total number of such drugs to 57, People’s Daily Overseas Edition reported on July 31, 2018.
The Generic Quality Consistency Evaluation (GQCE), which has been carried out in China since 2015, is a mandatory bioequivalence test that promotes the quality of China’s domestic generic drugs.
An expert in the field said that the implementation of GQCE is expected to expand the domestic market, create a favorable development environment and promote fair competition for generic drugs, thus helping to lower drug prices.
In April, the Chinese government released a circular focused on improving the supply and utilization of generics, promoting the quality and efficacy of generic drugs, speeding up the implementation of the GQCE and enhancing quality control of drugs.
According to the circular, the country will provide favorable policies and support to qualified generic drugs in purchasing, pricing, medical insurance coverage and investment. Medical institutions should also give high priority to the use of generic drugs in clinical practice.
According to the GQCE, after the first three manufacturers of a kind of drug pass assessment stage, no other drug manufacturers will be granted a license to make this drug for the following three years.
An industry insider pointed out that the GQCE is a challenge for domestic generic drug manufacturers, because its implementation will reduce the number of generic drugs on the market by 60 percent. The assessment will, however, motivate manufacturers as the industry becomes normalized and institutionalized.
More than 10 Chinese cities have enacted policies to support the registration of approved generic drugs. For instance, Hubei province in central China has granted a “green passage” to simplify procedures when it comes to introducing approved generic drugs in hospitals.