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Angie Drakulich was editorial director of Pharmaceutical Technology.
FDA released a new strategy on that is aimed at meeting the challenges posed by rapidly rising imports of FDA-regulated products and the growing complexity of the pharmaceutical supply chain.
FDA released a new strategy on June 20, 2011, that is aimed at meeting the challenges posed by rapidly rising imports (they’ve quadrupled since 2000) of FDA-regulated products and the growing complexity of the pharmaceutical supply chain. A report titled “Pathway to Global Product Safety and Quality,” calls for four key changes to protect consumers:
“Global production of FDA-regulated goods has exploded over the past 10 years. 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,” said FDA Commissioner Margaret A. Hamburg in the announcement. “There has been a perfect storm—more products, more manufacturers, more countries and more access. A dramatic change in strategy must be implemented.”
In terms of how the new strategy and changing manufacturing environment will affect the pharmaceutical industry in the future, FDA’s announcement notes the following:
The strategy builds on recent agency efforts to increase the number of foreign inspections it conducts and to collaborate more with global regulatory authorities by, for instance, joining the Pharmaceutical Inspection Cooperation/Scheme (PIC/S).