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China: Blacklist System to Be Established for Pharmaceutical Safety

(Oct. 5, 2012) On August 13, 2012, China’s State Food and Drug Administration (SFDA) issued the Provisions for the Administration of a Drug Safety Blacklist (for Trial Implementation), to establish a blacklist system for pharmaceutical safety. The Provisions took effect on October 1, 2012. (Text of the Provisions [in Chinese], SFDA website (Aug. 15, 2012).)

According to the Provisions, the SFDA and its provincial-level counterparts will publish drug safety blacklists on their official websites. The blacklists are to contain information on pharmaceutical manufacturing and trading companies on which administrative penalties have been imposed due to their serious violation of laws and regulations regarding medicine and medical devices, as well as information on their directly responsible personnel. (Id. art. 2.)

The Provisions specify the circumstances under which a violator will be added to the blacklist, including:

1. having had a certificate or licenses for the manufacture or trade in medicine or medical devices revoked due to manufacturing or distributing counterfeit drugs or sub-standard drugs or medical devices or manufacturing medical devices without a license;

2. concealing relevant information or providing false materials when applying for relevant administrative permits; or

3. providing false documents, cheating, or giving bribes to obtain relevant administrative permits. (Id. art. 7.)

The SFDA and its provincial-level counterparts will add the information about a violator to their respective blacklists within 15 days of the date on which an administrative penalty decision takes effect. (Id. arts. 9-10.) The blacklist maintained by the SFDA will also contain information published on the provincial blacklists. (Id. art. 6.) In general, the blacklist information will stay online for two years from the day on which the penalty was imposed. (Id. art. 11.)