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Update – February 16, 2009
Establishing Overseas Offices
Sources at the FDA have explained that the FDA has opened an office
in China as part of the FDA’s “Beyond our Borders” program. This FDA
office is basically an oversight to make it easier for FDA to address
issues concerning matters related to FDA regulated problems. At this
time the FDA does not have “investigators” who will be performing plant
inspections. These plant inspections are still be performed by
investigators travelling from the US and controlled by Washington DC.
The FDA “Beyond Our Borders” program is explained as follows:
Establishing Overseas Offices
FDA is working to establish offices overseas in parts of the world where
the agency believes a much closer working relationship with its
counterpart regulators will help FDA do its work even better.
"The Beyond Our Borders initiative is transforming the map of our
workforce," says FDA Commissioner Andrew C. von Eschenbach, M.D. "The
posting of FDA staff in overseas regions will greatly expand our
oversight of imported food and medical products."
FDA's in-country offices will allow the agency to:
• build or further strengthen a trusted regulator-to-regulator
relationship
• learn more about the industries and challenges of how products are
regulated in these countries
• more easily inspect manufacturing and processing facilities in these
countries or determine how FDA can further leverage inspections already
performed by its counterparts in certain regions, such as Europe
• have increased interactions with foreign manufacturers to help ensure
that products shipped to the United States meet FDA standards for safety
and manufacturing quality
• verify that imported products and the way they are manufactured meet
U.S. health and safety requirements
In November 2008, Secretary of Health and Human Services Mike Leavitt
and FDA Commissioner von Eschenbach opened FDA's first overseas offices
in China. China is a major producer and exporter of FDA-regulated
products to the United States. FDA's China offices are set up to
accommodate eight FDA experts from the United States and five local
Chinese nationals. In addition to senior technical experts in Beijing,
the U.S. contingent will include inspectors who will work out of offices
in Shanghai and Guangzhou.
Other planned locations for FDA offices are India, Europe, Latin
America, and the Middle East. FDA's goal is to have directors in place,
as well as some staff hired, in most of these regions by the end of
2008.
"By promoting food and drug safety and quality, and helping to raise
standards beyond our borders, we can better protect Americans while they
continue to enjoy the benefits of the global marketplace," says Lumpkin,
"and more importantly, contribute to the overall public health of our
global community."
For more information on this please contact mdi at
info@mdiconsultants.com.
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