China NMPA Issues New Regulation on Pharmaceutical Recalls

According to the new Administrative Measures for Drug Recalls issued on October 26, 2022, Marketing Authorization Holders (MAHs) of drug products are responsible for drug recalls, not drug manufacturers. More specifically, hospitals, drug makers, and drug suppliers are only responsible for helping Chinese MAHs with drug recalls. MAHs are in charge of the main responsibilities such as setting up the system for drug recalls, compiling and analyzing information on the quality and safety of the products, and recalling the drugs with quality or safety issues. With respect to drug products that are marketed in China but manufactured overseas, the overseas MAHs need to have their Chinese local agent implement recalls.

There are two types of drug recalls – 1. voluntary recalls done voluntarily by MAHs if they find any quality or safety issues and 2. mandatory recalls mandated by the local Health Authorities and implemented by the MAHs. If MAHs fail to carry out the mandated drug recalls, they can be penalized up to 10 times the value of the drugs or 100,000 RMB (about 13,700 USD) if the drug is worth less than 10,000 RMB (about 1,370 USD). In some serious cases, the drug approval may be revoked. Drug suppliers, makers, and hospitals that fail to assist their MAHs with recalls will be penalized up to 500,000 RMB (about 68,400 USD).