FDA Beefing Up Inspections Presence in China

The FDA plans to triple its staff in China from 13 to 39, advancing a key agency goal of increasing the number of inspections it conducts in the country, the sixth largest exporter of drugs and biologics to the U.S.

In 2013, CDER and CBER combined inspected only 62 Chinese facilities.  And so far in 2014, the agency has issued just four warning letters to Chinese manufacturers.

The FDA’s staffing announcement comes on the heels of Commissioner Margaret Hamburg’s five-day trip to China where she signed an Implementing Arrangement with the China FDA, aimed at improving coordination between the agencies on drug quality issues. She said the FDA expects to sign a similar Implementing Arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ) in the coming weeks.

The agreements expand on previous cooperation between the two countries, including a 2007 pact in which China agreed to begin certifying that exported drugs meet agency standards and that it would notify the FDA within 24 hours when it discovered a problem that represents a significant public health concern.

The staffing increase is long overdue, having first been authorized in 2011, Michael Burke, a partner at law firm Arnall Golden Gregory, said. The issue has been complicated by a delay by the Chinese government on issuing visas for new personnel, he added.

Prepare yourself for increased inspections in China by subscribing to FDAnews Inspection Insider today!