China to enforce blacklist for unsafe drugs

Regulations will come into force on 1 October

Regulations that call for the blacklisting of manufacturers of unsafe drugs will come into effect in China on 1 October as part of a push to improve medical safety in the country.

China’s State Food and Drug Administration (SFDA) says that information regarding the manufacturers and those found responsible for severe violations of relevant laws will be included in a list that will be posted on government websites for public supervision.

The blacklist will include those involved in the production or sale of counterfeit or inferior drugs, as well as those who have produced unregistered medical devices, or those that fail to meet national or industry standards.

In addition, those who falsify or conceal information when applying for permits/approvals, or who use fraud or bribery to obtain permits/approvals using false documentation, data or samples will be named.

Failure to comply with GMPs or other legal requirements in production or distribution that result in serious safety incidents will result in a company being included on the blacklist, as well as obstruction of SFDA investigations (e.g. forgery, intentional destruction/concealment of information or documentation).

The consequences of being blacklisted will include denial of applications filed during the prohibition period, increased frequency of inspections and product quality testing, information sharing with other governmental agencies and penalties to companies who hire blacklisted individuals within 10 years of the violation.

The SFDA says these lists will be published on government websites of both the regulator and provincial/local regulators for public supervision.