China's SFDA Issues Rule on Imposing Administrative Penalties

Posted 08 November 2012 | By Ansis Helmanis 

China's State Food and Drug Administration (SFDA) issued a notice to the Provinces and Autonomous Regions regarding the application of its Administrative Punishment law, which sets forth the rules for imposing sanctions for violations of the laws and regulations governing drugs and devices. 

Local authorities are allowed leeway in deciding the severity of the penalty that is to be imposed on a case-by-case basis, taking into consideration the nature of the violation, the circumstances involved and the level of "harmful effects." The rules will become effective as of 1 January 2013.

The rules call for "heavier punishment" to be imposed for the following offenses:

  • Counterfeit drugs, narcotic drugs, psychotropic substances, medicinal toxic drugs, radioactive drugs;
  • Production and sale of counterfeit and substandard drugs for pregnant women, infants, and children;
  • Production and sale of counterfeit or substandard biological products, blood products, injection drugs; 
  • Production and sale of counterfeit or substandard drugs or medical devices, resulting in personal injury; 
  • Production and sale of counterfeit or substandard drugs or medical devices, by repeat offenders; and,
  • Evading supervision and inspection by falsifying, destroying, or concealing relevant evidence material of unauthorized goods. 

Lighter penalties may be imposed in the following circumstances:

  • Taking the initiative to eliminate or mitigate violations and harmful consequences;
  • Being coerced by another to violate the law; and,
  • Performing "meritorious" service with the food and drug administration department of medicine and medical equipment.

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