Increased Monitors for Drug Safety in China

Due to the onslaught of major drug and food safety incidents in China, there are a number of measures being taken by the Chinese State Food and Drug Administration (SFDA) to ensure safety and quality of pharmaceuticals and food products at the point of manufacture.

The SFDA recently established a national center in hopes to reduce the response time toward safety incidents for pharmaceutical, cosmetic, and food products. As a subsidiary of the SFDA, it will also be charged with the responsibilities of documenting, investigating, and publishing consumer complaints. In the case of safety risk outbreaks and recalls, the national center will be responsible for coordinating all responsive actions.

The SFDA will also increase the number of drugs listed and monitored through the electronic system launched in 2006. There are currently 56,000 drugs in the system’s database, and these pharmaceuticals are monitored for quality and safety throughout the drug’s entire production and circulation process. The expansion of the electronic monitoring system will allow the SFDA to more timely and effectively respond to drug safety risks. It will also better prevent counterfeit drugs from entering China’s pharmaceutical market.

China’s SFDA is also cooperating with the U.S. Food and Drug Administration (FDA), who recently opened an overseas branch in Beijing to regulate the safety and quality of China-made food and medicine exported to the United States. The additional oversight and enforcement will better certify that products produced in China for international use adhere to the enforced standards. However, because the number of FDA inspectors in China is limited, they cannot oversee China’s vast pharmaceutical sector.