China to Implement Additional GMP Regulations: An Update

In 1998, China’s State Food and Drug Administration (SFDA) introduced Good Manufacturing Practice (GMP) certification in order to emphasize quality and safety of pharmaceutical production. However, the certification was optional and occurrences of medical accidents and legal issues continued to arise due to poor manufacturing practices. Following China’s entry into the World Trade Organization (WTO) in 2001, as well as from the added pressure of the international drug community, the SFDA implemented a new regulation requiring GMP certification for all pharmaceutical manufacturers in China in July 2004. At that time, approximately half of the 6,000 drug manufacturers in China had already received GMP certification; the other 3,000 manufacturers were granted a six month grace period to upgrade their technology in order to meet the new standards.

Following the July 2004 announcement, the SFDA issued another notice in October 2004, which revealed future GMP requirements for IVD reagents, medicinal gases and Chinese crude drugs. Manufacturers of IVD reagents (administered as drugs) will need to meet GMP standards by January 1, 2006. Beginning January 1, 2007, medicinal gas manufacturers will require GMP certification. Finally, producers of cut crude drugs for Chinese medicine will need to obtain GMP certification by January 1, 2008. GMP standards for Chinese crude drugs will involve how the manufacturer processes and contains the prepared slices of the drugs, including the cleaning, cutting and steaming processes. Any manufacturers who fail to meet GMP standards by their respective deadline will be forced by the SFDA to stop production.