National Academies Press: OpenBook
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

STRONGER
FOOD AND DRUG REGULATORY
SYSTEMS ABROAD

Committee on Stronger Food and Drug Regulatory Systems Abroad

Board on Global Health

Health and Medicine Division

Gillian J. Buckley and Catherine E. Woteki, Editors

A Consensus Study Report of

images

THE NATIONAL ACADEMIES PRESS
Washington, DC
www.nap.edu

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

THE NATIONAL ACADEMIES PRESS 500 Fifth Street, NW Washington, DC 20001

This activity was supported by contracts between the National Academy of Sciences and the Food and Drug Administration (#10004259). Any opinions, findings, conclusions, or recommendations expressed in this publication do not necessarily reflect the views of any organization or agency that provided support for the project.

International Standard Book Number-13: 978-0-309-67043-2
International Standard Book Number-10: 0-309-67043-8
Digital Object Identifier: https://doi.org/10.17226/25651

Additional copies of this publication are available from the National Academies Press, 500 Fifth Street, NW, Keck 360, Washington, DC 20001; (800) 624-6242 or (202) 334-3313; http://www.nap.edu.

Copyright 2020 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

Suggested citation: National Academies of Sciences, Engineering, and Medicine. 2020. Stronger food and drug regulatory systems abroad. Washington, DC: The National Academies Press. https://doi.org/10.17226/25651.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Image

The National Academy of Sciences was established in 1863 by an Act of Congress, signed by President Lincoln, as a private, nongovernmental institution to advise the nation on issues related to science and technology. Members are elected by their peers for outstanding contributions to research. Dr. Marcia McNutt is president.

The National Academy of Engineering was established in 1964 under the charter of the National Academy of Sciences to bring the practices of engineering to advising the nation. Members are elected by their peers for extraordinary contributions to engineering. Dr. John L. Anderson is president.

The National Academy of Medicine (formerly the Institute of Medicine) was established in 1970 under the charter of the National Academy of Sciences to advise the nation on medical and health issues. Members are elected by their peers for distinguished contributions to medicine and health. Dr. Victor J. Dzau is president.

The three Academies work together as the National Academies of Sciences, Engineering, and Medicine to provide independent, objective analysis and advice to the nation and conduct other activities to solve complex problems and inform public policy decisions. The National Academies also encourage education and research, recognize outstanding contributions to knowledge, and increase public understanding in matters of science, engineering, and medicine.

Learn more about the National Academies of Sciences, Engineering, and Medicine at www.nationalacademies.org.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Image

Consensus Study Reports published by the National Academies of Sciences, Engineering, and Medicine document the evidence-based consensus on the study’s statement of task by an authoring committee of experts. Reports typically include findings, conclusions, and recommendations based on information gathered by the committee and the committee’s deliberations. Each report has been subjected to a rigorous and independent peer-review process and it represents the position of the National Academies on the statement of task.

Proceedings published by the National Academies of Sciences, Engineering, and Medicine chronicle the presentations and discussions at a workshop, symposium, or other event convened by the National Academies. The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies.

For information about other products and activities of the National Academies, please visit www.nationalacademies.org/about/whatwedo.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

COMMITTEE ON STRONGER FOOD AND DRUG REGULATORY SYSTEMS ABROAD

CATHERINE E. WOTEKI (Chair), Professor, Iowa State University

LYSTRA ANTOINE, CEO of Global Food Safety Partnership, World Bank

MIKEL ARRIOLA, former Federal Commissioner, COFEPRIS; former General Director, Mexican Institute of Social Security

MARIA ELENA BOTTAZZI, Associate Dean and Professor, National School of Tropical Medicine, Baylor College of Medicine

JULIE CASWELL, Distinguished Professor Emeritus, University of Massachusetts Amherst

CLARE NARROD, Director of Risk Analysis Program, Joint Institute for Food Safety and Applied Nutrition, University of Maryland

JONATHAN QUICK, Senior Fellow Emeritus, Management Sciences for Health

JOSHUA SHARFSTEIN, Vice Dean and Professor, Johns Hopkins Bloomberg School of Public Health

MARKUS TAUSSIG, Associate Professor, Rutgers Business School

RAYMOND WIGENGE, former Director of Food and Safety, Tanzania Food and Drug Authority

VERONIKA WIRTZ, Associate Professor, Department of Global Health, Boston University School of Public Health

PRASHANT YADAV, Visiting Fellow, Center for Global Development; Affiliate Professor of Technology & Operations Management, INSEAD

Health and Medicine Division Staff

GILLIAN J. BUCKLEY, Study Director

ROMY NATHAN, Program Officer (from August 2019)

AMBAR SAEED, Research Associate

SARAH ANNE NEW, Senior Program Assistant (until April 2019)

MARGARET MCFARLAND, Senior Program Assistant (from May 2019)

JULIE PAVLIN, Director, Board on Global Health

National Academy of Medicine Fellow in Pharmacy

DIMA QATO, Associate Professor, University of Illinois at Chicago College of Pharmacy

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

This page intentionally left blank.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Reviewers

This Consensus Study Report was reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise. The purpose of this independent review is to provide candid and critical comments that will assist the National Academies of Sciences, Engineering, and Medicine in making each published report as sound as possible and to ensure that it meets the institutional standards for quality, objectivity, evidence, and responsiveness to the study charge. The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process.

We thank the following individuals for their review of this report:

JIE BAI, Harvard Kennedy School

ANA MARISA CORDERO, Inter-American Institute for Cooperation on Agriculture

KELLEY CORMIER, U.S. Agency for International Development

KENNETH HARTIGAN-GO, Asian Institute of Management Philippines

STEVEN M. JAFFEE, University of Maryland

PATRICK LUKULAY, Technology Solutions for Global Health

JOHN T. MONAHAN, Georgetown University

JUDE NWOKIKE, United States Pharmacopeial Convention

ALAIN PRAT, The Global Fund to Fight AIDS, Tuberculosis and Malaria

Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

CARLOS SANTOS-BURGOA, The George Washington University

ANDY STERGACHIS, University of Washington

JOSE VICENTE COTO UGARTE, Pan American Health Organization

Although the reviewers listed above provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations of this report nor did they see the final draft before its release. The review of this report was overseen by JIM E. RIVIERE, North Carolina State University and Kansas State University, and LYNN R. GOLDMAN, The George Washington University. They were responsible for making certain that an independent examination of this report was carried out in accordance with the standards of the National Academies and that all review comments were carefully considered. Responsibility for the final content rests entirely with the authoring committee and the National Academies.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Acknowledgments

This consensus study report is a product of the cooperation and contributions of many people. The committee and staff are especially grateful for the support of the National Academies of Sciences, Engineering, and Medicine staff, especially Daniel Bearss, Clyde Behney, Jeanay Butler, Anna Isabel Camilo Javier, Daniel Cesnalis, Kierra Chinn, Julie Eubank, Greta Gorman, Nicole Joy, Stephanie Miceli, Rebecca Morgan, Tina Seliber, Lauren Shern, Elizabeth Tyson, Julie Wiltshire, and Taryn Young. We also specially thank Rebekah Hutton for designing the report cover.

The committee’s overseas workshop went smoothly thanks to the warm hospitality from the National Academy of Sciences of Costa Rica, especially Walter Fernandez, Pedro Leon, and Dayana Mora.

Many people kindly introduced the Health and Medicine Division staff to key speakers. They are particularly grateful to Javier Guzman, Analia Porrás, and Mike Ward.

The committee thanks all the speakers and moderators who participated in committee meetings, as well as others who provided information, input, and assistance. They include Pawan Agarwal, Jean Carlo Apuy, Dirceu Barbano, Jarbas Barbosa, Rommel Anibal Betancourt Herrera, Marisa Caipo, Renata Clarke, Monique Collaço de Moraes Stávale, Ana Marisa Cordero, Kelley Cormier, Santiago Cornejo, Jose Vicente Coto Ugarte, Lissy Cruz, Tatiana Cruz Ramirez, Rivelino Flores, Juan Carlos Galarza, Iris Galeano, Delia Grace, Nuri Gras, Kenneth Hartigan-Go, Lisa Indar, Steven Jaffee, Barbara Kowalcyk, Larry Liberti, Lisa Ludeman, Mac Lumpkin, Gugu Mahlangu, Emilio Medina, Mario Montero, Uy Hong

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Nguyen, Jude Nwokike, Carolina Paz, Mayra Perez-Tapia, Anban Pillay, Elizabeth Pisani, Lembit Rago, Maria Angelica Sanchez-Herrera, Carlos Santos Burgoa, Katherine Serrano, Dilip Shah, Paula Vargas, Dali Young, and Ana Gabriel Zuniga.

We thank Hudu Mogtari of the African Union’s New Partnership for Africa’s Development program for his willingness to serve on the committee. Mr. Mogtari was obliged to resign from the committee before participating in any deliberations because of other commitments.

Finally, particular thanks to the U.S. Food and Drug Administration for generously funding this project.

Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

This page intentionally left blank.

Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×

Acronyms and Abbreviations

ADDO Accredited Drug Dispensing Outlet
AIDS acquired immunodeficiency syndrome
APEC Asia-Pacific Economic Cooperation
ASEAN Association of Southeast Asian Nations
AUDA African Union Development Agency
CDC U.S. Centers for Disease Control and Prevention
EFSA European Food Safety Authority
EMA European Medicines Agency
FAO Food and Agriculture Organization of the United Nations
FDA U.S. Food and Drug Administration
FSIS Food Safety and Inspection Service
GAP Good Agricultural Practices
GBT Global Benchmarking Tool
GFSI Global Food Safety Initiative
GFSP Global Food Safety Partnership
HACCP Hazard Analysis and Critical Control Point
HHS U.S. Department of Health and Human Services
HIV human immunodeficiency virus
Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
ICDRA International Conference of Drug Regulatory Authorities
ICH International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use
ICMRA International Coalition of Medicines Regulatory Authorities
IFC International Finance Corporation
IFPTI International Food Protection Training Institute
ILSI International Life Sciences Institute
IMDRF International Medical Device Regulators Forum
IMF International Monetary Fund
INFOSAN International Food Safety Authorities Network
IOM Institute of Medicine
ISO International Organization for Standardization
JIFSAN Joint Institute for Food Safety and Applied Nutrition
NAFDAC National Agency for Food and Drug Administration and Control
NCD noncommunicable disease
NEPAD New Partnership for Africa’s Development
NIH National Institutes of Health
OECD Organisation for Economic Co-operation and Development
OIE World Organisation for Animal Health
PEPFAR The President’s Emergency Plan for AIDS Relief
PVS Performance of Veterinary Services
SADCAS Southern Africa Development Community Accreditation Service
UN United Nations
UNIDO United Nations Industrial Development Organization
USAID U.S. Agency for International Development
USDA U.S. Department of Agriculture
WHA World Health Assembly
WHO World Health Organization
WTO World Trade Organization
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R1
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R2
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R3
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R4
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R5
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R6
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R7
Page viii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R8
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R9
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R10
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R11
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R12
Page xiii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R13
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R14
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R15
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R16
Page xvii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R17
Page xviii Cite
Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2020. Stronger Food and Drug Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/25651.
×
Page R18
Next: Summary »
Stronger Food and Drug Regulatory Systems Abroad Get This Book
×
Buy Paperback | $65.00 Buy Ebook | $54.99
MyNAP members save 10% online.
Login or Register to save!
Download Free PDF

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.

  1. ×

    Welcome to OpenBook!

    You're looking at OpenBook, NAP.edu's online reading room since 1999. Based on feedback from you, our users, we've made some improvements that make it easier than ever to read thousands of publications on our website.

    Do you want to take a quick tour of the OpenBook's features?

    No Thanks Take a Tour »
  2. ×

    Show this book's table of contents, where you can jump to any chapter by name.

    « Back Next »
  3. ×

    ...or use these buttons to go back to the previous chapter or skip to the next one.

    « Back Next »
  4. ×

    Jump up to the previous page or down to the next one. Also, you can type in a page number and press Enter to go directly to that page in the book.

    « Back Next »
  5. ×

    Switch between the Original Pages, where you can read the report as it appeared in print, and Text Pages for the web version, where you can highlight and search the text.

    « Back Next »
  6. ×

    To search the entire text of this book, type in your search term here and press Enter.

    « Back Next »
  7. ×

    Share a link to this book page on your preferred social network or via email.

    « Back Next »
  8. ×

    View our suggested citation for this chapter.

    « Back Next »
  9. ×

    Ready to take your reading offline? Click here to buy this book in print or download it as a free PDF, if available.

    « Back Next »
Stay Connected!