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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. Table of
Contents Front Matter Summary 1 Introduction 2 Core Elements of
Regulatory Systems 3 Critical Issues 4 A Strategy to Building Food
and Medical Product Regulatory Systems 5 International Action 6
Domestic Action 7 Conclusions and Priorities Appendix A: Glossary
Appendix B: A Review of Tort Liability's Role in Food and Medical
Product Regulation Appendix C: Food and Medical Product Regulatory
Systems of South Africa, Brazil, India, and China Appendix D:
Chinese Food Regulatory System Appendix E: Meeting Agendas Appendix
F: Committee Member Biographies Appendix G: Analyzing Food Safety
Alerts in European Union Rapid Alerts Systems for Food and Feed
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
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