Thursday, March 20, 2008
US FDA Setting Up Shop in China
Filed under: Regulation
The US Food and Drug Administration is setting up shop in The People's Republic of China. Well, at least a small shop manned by eight full time US FDA staff.
From the FDA:
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.
It's obvious that greater regulatory scrutiny needs to be applied to food and drugs (and medgadgets!) made in China, but we're doubtful that eight new employees, operating only with the permission of the notoriously restrictive, secretive and corrupt Chinese government, are really going to effect much change.
More from the US Food and Drug Administration...
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examples: <b>Bold</b> <i>Italic</i>
