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EYE ON CHINA
Chinese patients to see more affordable, high-quality generic drugs
CFDA brings total number of China’s domestic generic drugs to 57

The China Food and 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 31 July 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 favourable 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 utilisation 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 favourable 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 the 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 normalised and institutionalised.

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.

Source: People’s Daily

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APBN Editorial Calendar 2018
January:
Obesity / Outlook for 2018
February:
Searching for the fountain of youth
March:
Women in Science - Making a difference
April:
Digestive health in the 21st century - Trust your guts
May:
Dental health - The root to good health
June:
Cancer - Therapies and strategies for better patient outcomes
July:
Water management - Technologies for biotech and pharmaceutical industries
August:
Regenerative technology - Meat of the future
September:
Doctor Robot - The digital healthcare revolution
October:
Bones / Breast cancer
November:
Liver health / Top science research nations & institutions
December:
AIDS / Breakthrough of the year/Emerging trends
Editorial calendar is subjected to changes.
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