China Proposes Tightening Rules, Reporting Requirements on Pharmaceutical Recalls

In response to growing concern that pharmaceuticals imported to China do not always adhere to the same safety guidelines they follow when marketed abroad, Chinese health authorities in October put forward a proposal to update domestic regulations governing drug recalls.

The proposed updates would be the first to China’s rules on recalls of pharmaceuticals since 2007, when the CFDA (prior to the NMPA) strengthened its drug recall rules to encourage manufacturers to start recalling drugs voluntarily when merited by the evidence.

The updates would obligate manufacturers to report to the Chinese authorities any recalls of their products outside China, even those not sold in China. It also requires market authorization holders to establish a program to trace drug sales within China, and it adds a new definition of drugs found to contain quality defects or that compromise quality or safety by hazards involved in storage, transportation, or development, among other factors.