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FDA Plans for Full-time Staff in China
In the category of finally, or "its about time", the FDA has announced plans to have permanent full time positions to monitor Chinese imports, such as the ingredients for Heparin. This comes in the wake of an increasing scandal related to Baxter's recall of Heparin following reports of deaths and hundreds of adverse reactions.
The FDA's press release follows:
FDA Takes Next Step in Establishing Overseas Presence
Agency on path to establish offices in China
In an important development, the U.S. Food and Drug Administration 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 an important step forward in the FDA's plans to hire and place FDA staff in China over the next 18 months. In addition, the FDA 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."
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 around the world 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.
For additional information on the FDA's international programs, please visit:
FDA International Programs.
For more information on the historic Memoranda of Agreement signed in December 2007, between the United States and The People's Republic of China, please visit:
Agreement Between China and US.
Next: Heparin Purity- China Doesn't Seem to Care
For information on the recall, click here:
FDA Information
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