system. This system benefits many, but it also presents new challenges. Individual countries can no longer depend on their national regulatory authorities to guarantee product safety in the domestic market. This report identifies the most pressing problems facing food and medical product regulators in developing countries. It outlines a strategy that can guide investments in regulatory capacity. It also recommends 13 specific actions the U.S. government and others could take to improve product safety and public health around the world.

The strategy for building regulatory systems and the 13 specific recommendations put forth in this report could do much to improve food and medical product safety in the United States and abroad. It was clear to the committee that product safety is a dynamic problem; it requires agile systems to respond to changing needs. The system should use enterprise risk management to inform its decisions. It is also clear that the FDA cannot act alone; it must develop ways to make the most of its extensive expertise and limited resources. Pooling data and planning inspections with other stringent regulatory agencies is an important first step. Other international organizations and regional communities are well-positioned to lead in training and education—key pieces of the solution. Finally, it has become clear that the FDA needs to refocus resources and attention on modern threats to the food and medical product supply. This will probably require rebalancing programs to give more attention to foreign producers and suppliers.



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