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Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad (2012)

Chapter: Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China

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Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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image

FIGURE C-1
Organization of the South African Food Control Directorate.

SOURCE: South African Food Control Directorate.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-2
Organization of the Brazilian food regulatory system.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-3
Organization of Indian food regulation.

SOURCE: USDA.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-4
Organization of Chinese food regulatory system.

SOURCE: Broughton and Walker, 2010.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-5
Organization of South African medical product regulatory system.

SOURCE: Government of South Africa.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-6
Organization of the Brazilian medical product regulatory system, ANVISA

SOURCE: ANVISA

Notes:

1. The ombudsman and consulting council are not subordinate to the collegiate board.

2. The Corregidor enforces laws and regulations within Anvisa.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-7
Indian drug control system, the Central Drugs Standard Control Organization.

SOURCE: Government of India.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

image

FIGURE C-8
Chinese drug regulatory system, State Food and Drug Administration (SFDA).

SOURCE: SFDA, 2011.

Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

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Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Page 275
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Page 276
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
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Page 277
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
Page 278
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
Page 279
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
Page 280
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
Page 281
Suggested Citation:"Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
Page 282
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A very high portion of the seafood we eat comes from abroad, mainly from China and Southeast Asia, and most of the active ingredients in medicines we take originate in other countries. Many low- and middle-income countries have lower labor costs and fewer and less stringent environmental regulations than the United States, making them attractive places to produce food and chemical ingredients for export. Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad explains that the diversity and scale of imports makes it impractical for U.S. Food and Drug Administration (FDA) border inspections to be sufficient to ensure product purity and safety, and incidents such as American deaths due to adulterated heparin imported from China propelled the problem into public awareness.

The Institute of Medicine Committee on Strengthening Core Elements of Regulatory Systems in Developing Countries took up the vital task of helping the FDA to cope with the reality that so much of the food, drugs, biologics, and medical products consumed in the United States originate in countries with less-robust regulatory systems. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad describes the ways the United States can help strengthen regulatory systems in low and middle income countries and promote cross-border partnerships - including government, industry, and academia - to foster regulatory science and build a core of regulatory professionals. This report also emphasizes an array of practical approaches to ensure sound regulatory practices in today's interconnected world.

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