Stronger Food and Drug Regulatory Systems Abroad

Ensuring the safety of food and the quality and safety of medicines in a country is an important role of government, made more complicated by global manufacturing and international trade. By recent estimates, unsafe food kills over 400,000 people a year, a third of them children under 5, mostly in low- and middle-income countries; every year poor quality medicines cause about 70,000 excess deaths from childhood pneumonia and roughly 8,500 to 20,000 malaria deaths in sub-Saharan Africa alone.

The Federal Drug Administration (FDA) Office of Global Policy and Strategy is charged with improving capacity of the agency's foreign counterpart offices and increasing understanding of the importance of regulatory systems for public health, development, and trade. At the request of the FDA, this study sets out a strategy to support good quality, wholesome food and safe, effective medical products around the world. Its goal is to build on the momentum for strengthening regulatory systems and to set a course for sustainability and continued progress.

The 2012 report Ensuring Safe Food and Medical Products Through Stronger Regulatory Systems Abroad outlined strategies to secure international supply chains, emphasized capacity building and support for surveillance in low- and middle-income countries, and explored ways to facilitate work sharing among food and medical product regulatory agencies. This new study assess progress made and the current regulatory landscape.

Table of Contents

• Front Matter
• Summary
• 1 Introduction
• 2 Regulatory Systems, Global Health, and Development
• 3 Global Efforts to Strengthen Regulatory Systems
• 4 The Role of the National Government
• 5 The Role of the Regulatory Agency
• Appendix A: Committee Member Biographies
• Appendix B: Public Meeting Agendas
• Appendix C: Call for Comments
• Appendix D: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad
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