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FDA Planning to Set Up Offices in China

By Biotechdaily staff writers
Posted on 17 Apr 2008
In an important development, the U.S. More...
Food and Drug Administration (FDA; www.fda.gov) has received approval from the U.S. State Department to establish eight full-time permanent FDA positions at U.S. diplomatic posts in the People's Republic of China, pending authorization from the Chinese government.

This is a significant step forward in the FDA's plans to hire and position FDA staff in China over the next 18 months. Moreover, the FDA will be hiring 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.”

Building the FDA's capacity outside of the United States supports the agency's "Beyond our Borders” initiative. The initiative facilitates the building of stronger cooperative relationships with the FDA's counterpart agencies worldwide and enhanced technical cooperation with foreign regulators. The 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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