Updated on 2 October 2012
Chinese SFDA to come up with a blacklist of fake drug and medtech firms
Singapore: The Chinese State Food and Drug Administration (SFDA) will implement a regulation on the management of a drug safety blacklist and this is expected to crack a whip on those individuals who produce drugs illegally, breach regulations on drugs and medical devices and on those who are subject to administrative punishment. These people will be blacklisted and named on an official government website and would be further supervised by the public, according to China Daily.
The SFDA said in a statement that, "Establishing the blacklist for drug safety strengthens safety supervision and the administration of drugs and medical devices, promotes the construction of a credit system and improves the industry's entry and exit mechanism. Meanwhile, it will also be conducive to supervising the producers to fully assume their responsibility for drug quality and safety and deterring illegal behavior."
Illegal manufacturers of drugs who have already received administrative punishment in seven kinds of situations will also be included on the blacklist. The first situation is that their licenses for working with medical institutions had been revoked for manufacturing or selling fake or substandard medicine. The second situation is that they didn't obtain a certificate to produce medical devices or produced ones that didn't accord with national regulations and industry standards.
Others situations include concealing the real situation or providing false materials when applying for administrative permits; using deception, bribery or other improper means to receive administrative permits; counterfeiting; deliberate destruction of an incident scene; concealing or destroying evidence; refusing or escaping supervision when under investigation of administrative penalty; being criminally accountable for illegal behavior involving drugs or medical devices, and producing or selling drugs or medical devices that cause serious medical incidents due to violation of laws and requirements.