Safety inspectors fail 100,000-plus doses of rabies personalized armbandsvaccines

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Drug regulators have denied market access to more than 100,000 doses of rabies vaccines produced in northeastern China in the past month, it was revealed Tuesday.

Some 43,510 doses from Maifeng Bio Tech Co failed premarket safety and efficacy checks on Oct 29, as did 57,290 doses from Zhuoyi Biological Co on Nov 11. Both manufacturers are based in Changchun, Jilin province.

The checks were conducted by the National Institutes for Food and Drug Control, which released the information about the substandard vaccines on its website.

On Oct 23, the authority also denied market access to 77,516 doses of a rabies vaccine made by Chengda Biotech in Shenyang, Liaoning province.

China tightened supervision of vaccines this year after a scandal involving Changsheng Bio-tech Co, a major vaccine maker that was found producing substandard products.

The National Medical Products Administration has pledged to prioritize building an online tracking system for vaccines, anesthetics and psychoactive drugs to ensure the safety of medicines.

On Nov 12, a draft vaccine law was released by the State Administration of Market Regulation for public feedback. If approved, companies that make illegal or substandard vaccines could face fines of up to 10 times the value of their products.


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2019-01-20 20:46:08


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