China: SFDA Proposes Blacklisting Companies

Posted 04 June 2012 | By Ansis HelmanisRegLink

China's State Food and Drug Administration (SFDA) has issued a draft "blacklist" proposal that would be used for listing serious violators of laws and regulations. The 28 May list was sent to provinces and municipalities, and contains examples of the kind of violations that would support blacklisting a company.

Examples provided include sales of counterfeit drugs, production and sale of inferior drugs, failure to obtain medical device registration certificate and device production which does not meet national standards.

The blacklist will also contain the personnel responsible for the regulatory violations rather than just the company to prevent personnel from establishing other companies or moving within the industry.

 

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SFDA - Proposed Blacklist

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