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FDA Moves Closer To Setting Up Shop In China

U.S. inspectors will ramp up drug, food safety inspections

By Mark Huffman
ConsumerAffairs.com

March 17, 2008

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The U.S. State Department has granted approval to the Food and Drug Administration to establish eight fulltime permanent FDA positions at U.S. diplomatic posts in the People's Republic of China. The move must also receive authorization from the Chinese government.

The Chinese outposts are a direct outgrowth of a number of highly publicized recalls last year involving products made in China. Among the most serious, the recall of tainted pet food falls under the FDA's jurisdiction.

The FDA said it plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA said it will be hiring a total of five local Chinese nationals to work with the new FDA staff at the U.S. Embassy in Beijing and the U.S. Consulates General in Shanghai and Guangzhou.

"In an age when a border is not a barrier, the globalized economy demands nothing less than heightened regulatory interoperability, information exchange, and cooperation, especially on product quality and enforcement matters," said Murray M. Lumpkin, M.D., deputy commissioner for International and Special Programs, FDA.

"Along with the important Memoranda of Agreement signed with two FDA counterpart Chinese agencies, our efforts to fill permanent FDA positions in China are a significant step toward ensuring access to safe food, drugs, and medical devices in the global market."

The agency said permanent overseas offices in China will also allow greater access for inspections and greater interactions with manufacturers to help assure that products that are shipped to the United States meet U.S. standards for safety and manufacturing quality.

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