News & Events
For Immediate Release: April 23, 2012
Media Inquiries: Gloria Sanchez,
301-796-7686, gloria.sanchez-contreras@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA strengthens international collaboration to ensure quality, safety of imported products
New report presents FDA’s focus on global cooperation for product safety
The U.S. Food and Drug Administration Commissioner
Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report1,” detailing the many activities
and strategies FDA is using to transform from a domestic to a global public
health agency.
The report describes the steps the agency is taking to ensure that imported
food, drugs, medical devices, and other regulated products meet the same
rigorous standards for safety and quality as those manufactured domestically.
“As our world transforms and becomes increasingly globalized, we must come
together in new, unprecedented, even unexpected, ways to build a public health
safety net for consumers around the world,” said FDA Commissioner Margaret A.
Hamburg, M.D.
Global production of FDA-regulated goods and materials has exploded over
the last decade and continues to grow. FDA-regulated products originate from
more than 150 countries, 130,000 importers, and 300,000 foreign facilities. Each
year from 2005-2011, food imports have grown by an average of 10 percent, while
imports of pharmaceutical products have increased at nearly 13 percent and
device imports have grown more than 10 percent. Approximately 50 percent of
fresh fruits and 20 percent of fresh vegetables, as well as 80 percent of the
seafood consumed in America come from abroad. Similarly, more than 80 percent of
the active pharmaceutical ingredients used to make medicines are imported.
The report outlines a variety of engagement strategies the FDA is using in
partnership with other agencies, organizations and coalitions around the world
to strengthen global, regulatory capacity-building efforts; develop and
harmonize science-based regulatory standards; increase awareness about the
importance of regulatory systems; and share information and data globally to
facilitate rapid identification of and response to public health
emergencies.
Through its international offices in Africa, Asia,
Europe, Latin America, and the Middle East, the FDA is increasing its knowledge
base about local regulatory systems and landscapes. The agency is also
increasing the understanding of foreign governments and industry of FDA
regulations and standards for products destined for U.S. consumers, and
collaborating to strengthen regulatory science and evidenced-based approaches to
product safety and quality. All of this furthers the FDA’s implementation of its
global strategy, set forth in the agency’s special report, Pathway to Global Product Safety and Quality2, released last year.
To access the Global
Engagement Report3, and
learn more about the FDA global work please visit the agency’s web page
dedicated to its work on globalization: www.fda.gov/global4. Also available are videotaped
remarks from Dr. Margaret Chan, Director General of the World Health
Organization: http://terrance.who.int/mediacentre/messages/MSG_FDA_CHANm_13APR2012.wmv5
6.
6.
The FDA, an agency within the U.S. Department of Health and Human Services,
protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
security of our nation’s food supply, cosmetics, dietary supplements, products
that give off electronic radiation, and for regulating tobacco products.
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