China to Reform Oversight of Drug Prices, GMP Compliance
China’s State Council is ordering the China Food and Drug Administration, and other agencies, to implement stricter policies to reform the country’s regulation of drug prices, GMP compliance and pharmaceutical marketing.
The sweeping reforms would affect major components of China’s drug system, tightening regulations for approval, manufacturing and distribution of medicines, according to a summary of the State Council’s directive by the law firm Sidley Austin.
Under the policy, the CFDA is required to enhance monitoring of GMP compliance, create a registry of medical representatives, and improve approval procedures as well as good clinical practice inspections. Some of the orders are at odds with China’s laws, which complicates their implementation, the law firm said.