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.
Table of Contents
|2 Core Elements of Regulatory Systems||33-78|
|3 Critical Issues||79-146|
|4 A Strategy to Building Food and Medical Product Regulatory Systems||147-164|
|5 International Action||165-192|
|6 Domestic Action||193-234|
|7 Conclusions and Priorities||235-242|
|Appendix A: Glossary||243-252|
|Appendix B: A Review of Tort Liability's Role in Food and Medical Product Regulation||253-272|
|Appendix C: Food and Medical Product Regulatory Systems of South Africa, Brazil, India, and China||273-282|
|Appendix D: Chinese Food Regulatory System||283-296|
|Appendix E: Meeting Agendas||297-318|
|Appendix F: Committee Member Biographies||319-328|
|Appendix G: Analyzing Food Safety Alerts in European Union Rapid Alerts Systems for Food and Feed||329-344|
|Appendix H: Strengthening Core Elements of Regulatory Systems in Developing Countries: Identifying Priorities and an Appropriate Role for the U.S. Food and Drug Administration||345-348|
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