China's new blacklist: the impact for drug and device lawbreakers

摘要

On 1 October 2012, new rules will become effective in China under which the country's healthcare products regulators will establish and publicise blacklists of companies and individuals that have been found, through administrative or judicial proceedings, to have committed a serious violation of drug or device law. Companies and individuals engaged in the research, development, manufacturing and distribution of drugs or devices in China need to be aware of the serious implications of the blacklists. They will have to comply diligently with the new rules in order to mitigate corporate or individual liability and business interruption. The Rules on Administration of Blacklist for Drug Safety (Trial Implementation) were promulgated by the State Food and Drug Administration on 13 August, finalising an SFDA proposal that was published on 30 May; although the title of the regulation does not include medical devices, the rules apply to device manufacturers and distributors as well. Under the rules, the SFDA and provincial food and drug administrations must each establish and publicise a blacklist of companies and individuals that have committed certain serious violations and they must update the blacklists periodically on their websites.The blacklist will contain the names and details of the violating companies and, in certain situations, those individuals who are direct managers or otherwise directly responsible for the violations (responsible individuals). Through this "naming and shaming" mechanism, the SFDA has indicated its intention to deter violations and increase enforcement activities against companies or individuals that have violated certain laws and regulations.