China: US FDA Seeks Larger Budget for Inspections

In its 2014 budget request, the US FDA is seeking an additional $10 million to increase its food and drug inspections in China. More than $4.7 million of the increase would go toward the drug inspection office. The China drug office hopes to add 9 full time staff in 2014.

The new staff would support an increased number of inspections of Chinese drug and API manufacturing facilities in 2014. It would also support an increase in the number of training sessions for Chinese drug authorities and manufacturers. Currently, the FDA holds training workshops throughout the year across China. These sessions educate Chinese manufacturers on the proper implementation of FDA efficacy and safety standards, and Chinese regulators on proper inspection techniques.

According to the FDA budget request, strengthening the supply chain for foods, drugs, and ingredients manufactured in China is one of the FDA’s top three goals for 2014. Enhancing the capacity of Chinese regulators and manufacturers is key to assuring the safety of Chinese drug exports to the US.

“The result will be fewer import safety emergencies, less foodborne illness and earlier identification of safety problems associated with foods, drugs, and ingredients manufactured in China,” the report said.

Altogether, the FDA conducted 813 overseas inspections in 2012, an increase of 10 percent from 2011.