FDA Setting Up Shop in China

The FDA is establishing three permanent offices in China to monitor device, drug and food safety that will be staffed by eight FDA employees along with five Chinese nationals to assist them.

The State Department has approved the plan, but the Chinese government has yet to do so. The posts are to be established by September 2009 at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou as part of the FDA’s Beyond Our Borders initiative.

The new FDA offices in China will give the agency greater access to local manufacturing facilities for inspections and improve its interactions with Chinese manufacturers, helping ensure that products shipped to the U.S. meet its standards for safety and manufacturing quality.

The offices also will improve regulatory interoperability, information exchange and cooperation on product quality and enforcement matters, Murray Lumpkin, deputy commissioner for International and Special Programs at the FDA, said. The FDA recently signed cooperation agreements with two corresponding Chinese regulatory agencies, he added.