China’s State Food and Drug Administration issued a notice in early November 2012 establishing new guidelines for its Administrative Punishment Law as applied to medical device and pharmaceutical manufacturers.
While local Chinese authorities are given increased decision power in the severity of penalties on a case-by-case, the new guidelines do specify certain areas for severity and other areas for leniency. The rules seem to follow a common-sense approach, with increased penalties for counterfeit, toxic, radioactive, and hallucinogenic drugs. “Substandard” or “counterfeit” drugs or medical devices that cause personal injury, repeatedly violate standards, or that deliberately evade inspection are also targeted for increased severity.
Conversely, manufacturers who are coerced into violating the law, clearly make efforts to correct the harmful aftereffects, or perform “meritorious” service for the SFDA can expect lighter penalties.