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.

Contents

• THE NATIONAL ACADEMIES
• COMMITTEE ON STRENGTHENING CORE ELEMENTS OF REGULATORY SYSTEMS IN DEVELOPING COUNTRIES
• Reviewers
• Foreword
• Acknowledgments
• Acronyms and Abbreviations
• Summary
  • CORE ELEMENTS OF REGULATORY SYSTEMS
  • CRITICAL ISSUES IN DEVELOPING COUNTRY FOOD AND MEDICAL PRODUCT SAFETY SYSTEMS
  • STRATEGY FOR BRIDGING THESE GAPS
  • INTERNATIONAL ACTION
  • DOMESTIC ACTION
  • CONCLUSION
• 1. Introduction
  • THE CHANGING FACE OF THE FDA
  • CHARGE TO THE COMMITTEE
  • THE BUILDING OF A MODERN REGULATORY AGENCY
  • MODERN FOOD AND DRUG CONTAMINANTS TRAVEL FAR AND FAST
  • REPORT STRUCTURE
  • REFERENCES
• 2. Core Elements of Regulatory Systems
  • COMMON ATTRIBUTES OF EFFECTIVE REGULATORY PROGRAMS
  • CORE ELEMENTS OF A STRONG REGULATORY SYSTEM
  • MINIMAL ELEMENTS OF A REGULATORY SYSTEM
  • FOOD AND MEDICAL PRODUCT REGULATION IN DEVELOPING COUNTRIES
  • HARMONIZATION
  • COOPERATION AMONG REGULATORY AGENCIES
  • RISK AND SHARED REGULATORY RESPONSIBILITY
  • CONCLUSION
  • REFERENCES
• 3. Critical Issues
  • ADHERENCE TO INTERNATIONAL STANDARDS
  • CONTROLLING SUPPLY CHAINS
  • INFRASTRUCTURE
  • LAWS
  • WORKFORCE
  • FRAGMENTATION
  • SURVEILLANCE
  • COMMUNICATION
  • POLITICAL WILL
  • CONCLUSION
  • REFERENCES
• 4. A Strategy to Building Food and Medical Product Regulatory Systems
  • GLOBAL HEALTH, TRADE, AND DEVELOPMENT
  • STRATEGY FOR BRIDGING THE GAPS IN FOOD AND MEDICAL PRODUCT REGULATION
  • THE ORGANIZATION OF THE COMMITTEE’S RECOMMENDATIONS
  • REFERENCES
• 5. International Action
  • INCREASING INTERNATIONAL INVESTMENTS
  • ENCOURAGING OPEN DIALOGUE AMONG GOVERNMENT, INDUSTRY, AND ACADEMIA IN EMERGING ECONOMIES
  • WORKING TOWARD SHARED INSPECTIONS
  • SHARING INSPECTION RESULTS VOLUNTARILY
  • STRENGTHENING SURVEILLANCE SYSTEMS
  • CONCLUSIONS
  • REFERENCES
• 6. Domestic Action
  • USING RISK AS A GUIDING PRINCIPLE
  • USING INFORMATION TECHNOLOGY
  • BRIDGING TRAINING GAPS AT HOME AND ABROAD
  • LEADERSHIP IN ADOPTING STANDARDS
  • EXPANDING ONE-UP, ONE-BACK TRACK AND TRACE
  • RESEARCHING INEXPENSIVE TECHNOLOGY
  • GIVING MARKET INCENTIVES FOR SUPPLY CHAIN MANAGEMENT
  • INCREASING CIVIL LIABILITY
  • CONCLUSION
  • REFERENCES
• 7. Conclusions and Priorities
  • ENTERPRISE RISK MANAGEMENT AS A TOOL TO SET PRIORITIES
  • A 3- TO 5-YEAR STRATEGY FOR THE FDA
  • POLITICAL WILL TO IMPLEMENT THE COMMITTEE’S RECOMMENDATIONS
  • CONCLUSIONS
  • REFERENCES
• 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

This study was supported by Contract No. HHSF22301015T, TO #18 between the National Academy of Sciences and the U.S. Food and Drug Administration. Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

Suggested citation:

IOM (Institute of Medicine). 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine. The members of the committee responsible for the report were chosen for their special competences and with regard for appropriate balance.