Regulatory Focus™ > News Articles > China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

China Finalizes Guidance Approving Counterfeit Manufacturer 'Black Lists'

Posted 16 August 2012 | By Louise Zornoza 

China's State Food and Drug Administration (SFDA) issued new regulations on 15 August instructing provincial governments to publish on their websites so-called Black Lists of drug and device companies that engage in counterfeiting and related illegal activities.  

The websites are to include the name of the company, its business address, the name of the legal representative or responsible person, and the individual's title.  Violations that would justify adding a company to a Black List include: production and sale of counterfeit drugs, manufacture of devices without having obtained a license, entering false information on registration certificates, and fraud and bribery.

The guidance comes just two months after the black lists were first proposed by SFDA.


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