China’s New and Updated GMP Regulations for Medical Products


China’s State Food and Drug Administration (SFDA) first issued the Good Manufacturing Practice (GMP) for Pharmaceutical Products in 1988 to regulate the quality of drugs that are made in China. This regulation was recently revised and the latest GMP regulation is known as the Good Manufacturing Practice for Pharmaceutical Products (2010 revised edition) or the “new version of GMP.” On March 1, 2011, this new version of GMP will be implemented.

After implementation, new pharmaceutical manufacturers will be required to comply with the new standards. At a later point in time, existing drug manufacturing facilities will need to meet this new regulation. The deadline to comply will be less than five years from the date of the implementation.

The new version of the GMP has been issued to improve the quality of manufactured drugs. For example, there are more standards that distinguish between GMP hardware and GMP software used by drug manufacturing facilities. More specific clauses have also been added to better enforce the way records on manufacturing procedures are maintained. Other clauses improve the way the concept of risk management is addressed and enhance security measures. Additionally, changes have been made to allow for greater consistency with the World Health Organization’s GMP.

Medical Devices

As of January 1, 2011, the notifications entitled “Quality Management System Regulations for Medical Devices (interim)” and “Requirements for Medical Device Quality Management System Inspection (interim)” were officially released. Currently, only sterile and implant medical devices are regulated under these new government quality regulations in China.