FDA sets out plans to keep closer eye on imports quality
The Pathway to Global Product Safety and Quality report is designed "to meet the challenges posed by rapidly rising imports of FDA-regulated products and a complex global supply chain". It calls for the agency "to transform the way it conducts business and to act globally in order to promote and protect the health of US consumers".
The FDA says it will partner with its counterparts worldwide to create global coalitions of regulators "focused on ensuring and improving global product safety and quality". These coalitions will develop international data information systems and networks, while the agency intends to build in "additional information gathering and analysis capabilities with an increased focus on risk analytics and information technology". It will also "leverage the efforts of public and private third parties and industry and allocate FDA resources based on risk".
Agency Commisioner Margaret Hamburg said "global production of FDA-regulated goods has exploded over the past ten years" and in addition to an increase in imported finished products, "manufacturers increasingly use imported materials and ingredients in their US production facilities, making the distinction between domestic and imported products obsolete". She added that "there has been a perfect storm - more products, more manufacturers, more countries and more access", therefore "a dramatic change in strategy must be implemented."
FDA-regulated imports have quadrupled since 2000 to 24 million shipments, Dr Hamburg went on, saying that the agency and its global regulatory counterparts "recognise this new reality and realise we must work proactively and collaboratively".
John Taylor, acting principal deputy commissioner of Food and Drugs, added that “in order to cope with the fundamental global shifts on the horizon, the FDA will have to substantially and fundamentally revise our approach to global product safety. We can no longer rely on historical tools, activities and approaches".
By Kevin Grogan
PharmaTimes
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