China 2015 Annual Report of Drug Inspection

On June 6, 2016, the CFDA released the 2015 Annual Report of Drug Inspection, an English-language report summarizing the findings of drug inspections carried out in China in 2015. The report is an effort to improve openness and accountability by the CFDA, and to communicate information effectively to the outside world. The report analyzes Chinese GMP inspections and discusses the CFDA’s efforts to model other global regulatory agencies’ inspections. It examines issues that include data integrity, frequent defective manufacturing of sterile products, and non-compliance with Chinese GMP standards in inspections completed outside of China.