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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012) / Chapter Skim
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7 Conclusions and Priorities
Pages 235-242

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From page 235...
... Table 4-1 describes how the committee used the problems identified in Chapter 3 as its targets in forming its recommendations. Chapters 5 and 6 describe the actions the committee believes would protect the safety of the food and medical product supply and build the capacity for reliable regulation in developing countries.
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From page 236...
... The committee recommends that the FDA choose which foreign offices to scale up, what topics to cover in trainings, and how to assign its staff using a scientific risk analysis. Some aspects of the FDA's governing plan seem informed by modern risk management.
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From page 237...
... First among these is the use of enterprise risk management to allocate funding and staffing to the FDA's foreign programs. Only over time, after Congressional approval, could the agency make similar adjustments to align its domestic actions with risk management principles.
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From page 238...
... . The committee believes that market incentives can strengthen the global supply chain and that access to hard-currency markets such as the United States can be that incentive.
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From page 239...
... This will take more than 10 years to realize, but the investments in training that the FDA could contribute both alone and through existing networks could improve product safety and strengthen the health system in developing countries. CONCLUSIONS This report presents the work of the IOM Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries in answer to the task given by the FDA and shown in Box 1-1.
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From page 240...
... Table 7-1 lists the sections of the report that respond to each question. In accordance with the statement of task's last paragraph, the committee gave the most attention to the problems of the emerging manufacturing nations that do the most trade with the United States.
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From page 241...
... The committee concluded that developing countries have consistent problems with adherence to international standards, controlling supply chains, infrastructure deficits, laws, their workforce, institutional fragmentation, surveillance, communication, and political will. The 13 recommendations put forth in this report represent the committee's consensus view of how to best bridge the gaps in food and medical product regulatory systems in low- and middle-income countries.
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Key Terms

  • supply chain
  • enterprise risk
  • medical product
  • product safety
  • core elements

  • global health
  • health strategy
  • risk analysis
  • global supply
  • developing country

  • country regulatory
  • secure supply
  • regulatory science
  • product regulatory
  • existing networks

  • international health
  • regulatory workforce
  • improve product
  • scientific risk
  • chain pilot

  • chain management
  • pilot program
  • risk evaluation
  • traceability requirements
  • strengthening core

  • product supply
  • subordinate agencies
  • meetings informed
  • public statements
  • congressional approval


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