Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad

This book 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. 

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. 

Contents

Acknowledgments

Acronyms and Abbreviations

Summary

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 В A Review of Tort Liability's Role in Food and Medical Product Regulation

Appendix С 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

Download