Saturday 25 March 2017

FDAUpdate

FDA Strengthens International Collaboration to Ensure Quality, Safety of Imported products

The FDA’s Global Engagement Report shed light on the volume of imported food, medical devices, and pharmaceuticals and outlines the measures taken by the Agency to ensure those products are as safe as their domestically produced counterparts. The Report finds 80% of seafood, 50% of fresh fruit, and 20% of fresh vegetables are imported each year. It’s of little surprise then the impact the Food Safety Modernization Act is having on foreign producers with provisions like the foreign supplier verification program.

The Report also states that 35% of medical devices are imported into the US. The Report expresses the Agency’s keen awareness of the dangers posed by imposed by imoprted devices. According to the Report, “Due to the high profit potential, imported medical products are vulnerable to economically motivated actions that can pose a significant risk to consumers.

As the US continues to monitor imports and audit foreign facilities an appropriate look at US regulations for pre-market approval and post-market surveillance are critically important.

More from the FDA:

he U.S. Food and Drug Administration Commissioner Margaret A. Hamburg, M.D. today released the agency’s “Global Engagement Report,” 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 Quality, released last year.
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