In an effort to further investigate the position in emerging economies, FDA commissioned the Institute of Medicine ("IOM") to study and identify the core elements of food, drug, medical product, and biologics regulatory systems in developing countries with a view to identifying the main gaps in those systems and to design a strategy for FDA and other stakeholders, which can be used to strengthen the food and medical products regulatory systems abroad. FDA is under relentless pressure to increase the number of inspections it carries out of foreign medicinal product manufacturers. However, FDA cannot do this without help and without substantial improvements in the capacity of their counterpart agencies, particularly those in emerging economies.
The report compiled by the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries and entitled "Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad" put forward several recommendations as to how the United States can play its part in helping strengthen the regulatory systems in low- and middle-income countries by promoting cross-border partnerships, including government, industry, and academia, to foster regulatory science and build a core of regulatory professionals. In putting together their report IOM staff travelled to China, Brazil, South Africa, and India to meet with regulators, representatives of regulated industry, academics, and health and development workers.
The IOM recommended that the FDA should use enterprise risk management to assist its inspection, training, regulatory cooperation, and surveillance efforts and should facilitate training for regulators in developing countries. The objective being workforce training and professional development through an ongoing, standard regulatory science and policy curriculum. The IOM stated that, "[E]nsuring the safety of food and medical products imported from around the world is a difficult task, and one that the FDA has executed fairly successfully so far. There is no reason to believe that their luck will hold over the next 10 years without substantive improvements in the capacity of their counterpart agencies abroad."