National Academies Press: OpenBook
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Ensuring Safe Foods
and Medical Products
Through Stronger
Regulatory Systems Abroad



Committee on Strengthening Core Elements of Food and Drug
Regulatory Systems in Developing Countries

Board on Global Health and the Board on Health Science Policy

Jim E. Riviere and Gillian J. Buckley, Editors

INSTITUTE OF MEDICINE

OF THE NATIONAL ACADEMIES

THE NATIONAL ACADEMIES PRESS

Washington, D.C.

www.nap.edu

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

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

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.

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.

International Standard Book Number-13: 978-0-309-22408-6
International Standard Book Number-10: 0-309-22408-X

Additional copies of this report 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.

For more information about the Institute of Medicine, visit the IOM home page at: www.iom.edu.

Copyright 2012 by the National Academy of Sciences. All rights reserved.

Printed in the United States of America

The serpent has been a symbol of long life, healing, and knowledge among almost all cultures and religions since the beginning of recorded history. The serpent adopted as a logotype by the Institute of Medicine is a relief carving from ancient Greece, now held by the Staatliche Museen in Berlin.

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

Photo credits:
Front cover
©2007 Natalie Moraru, Courtesy of Photoshare
Back cover, from top to bottom
© 2009 Joydeep Mukherjee, Courtesy of Photoshare
© 2006 Morgan Rog, Courtesy of Photoshare
© 2009 Wendy Leonard, Courtesy of Photoshare

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

 

“Knowing is not enough; we must apply.
Willing is not enough; we must do.”
—Goethe

image

INSTITUTE OF MEDICINE

               OF THE NATIONAL ACADEMIES

Advising the nation. Improving Health.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

THE NATIONAL ACADEMIES

Advisers to the Nation on Science, Engineering, and Medicine

The National Academy of Sciences is a private, nonprofit, self-perpetuating society of distinguished scholars engaged in scientific and engineering research, dedicated to the furtherance of science and technology and to their use for the general welfare. Upon the authority of the charter granted to it by the Congress in 1863, the Academy has a mandate that requires it to advise the federal government on scientific and technical matters. Dr. Ralph J. Cicerone is president of the National Academy of Sciences.

The National Academy of Engineering was established in 1964, under the charter of the National Academy of Sciences, as a parallel organization of outstanding engineers. It is autonomous in its administration and in the selection of its members, sharing with the National Academy of Sciences the responsibility for advising the federal government. The National Academy of Engineering also sponsors engineering programs aimed at meeting national needs, encourages education and research, and recognizes the superior achievements of engineers. Dr. Charles M. Vest is president of the National Academy of Engineering.

The Institute of Medicine was established in 1970 by the National Academy of Sciences to secure the services of eminent members of appropriate professions in the examination of policy matters pertaining to the health of the public. The Institute acts under the responsibility given to the National Academy of Sciences by its congressional charter to be an adviser to the federal government and, upon its own initiative, to identify issues of medical care, research, and education. Dr. Harvey V. Fineberg is president of the Institute of Medicine.

The National Research Council was organized by the National Academy of Sciences in 1916 to associate the broad community of science and technology with the Academy’s purposes of furthering knowledge and advising the federal government. Functioning in accordance with general policies determined by the Academy, the Council has become the principal operating agency of both the National Academy of Sciences and the National Academy of Engineering in providing services to the government, the public, and the scientific and engineering communities. The Council is administered jointly by both Academies and the Institute of Medicine. Dr. Ralph J. Cicerone and Dr. Charles M. Vest are chair and vice chair, respectively, of the National Research Council.

www.national-academies.org

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

COMMITTEE ON STRENGTHENING CORE ELEMENTS OF REGULATORY SYSTEMS IN DEVELOPING COUNTRIES

JIM E. RIVIERE (Chair), Burroughs Wellcome Fund Distinguished Professor of Pharmacology; Director, Center for Chemical Toxicology Research and Pharmacokinetics, College of Veterinary Medicine, North Carolina State University, Raleigh

THOMAS BOLLYKY, Senior Fellow, Global Health, Economics, and Development, Council on Foreign Relations, Washington, DC

CORRIE BROWN, Josiah Meigs Distinguished Teaching Professor, Department of Veterinary Pathology, College of Veterinary Medicine, University of Georgia, Athens

MARTHA BRUMFIELD, President, Martha A. Brumfield, LLC, New York, NY

ROBERT BUCHANAN, Professor and Director, Center for Food Safety and Security Systems, University of Maryland, College Park

JAKE YUE CHEN, Director, Indiana Center for Systems Biology and Personalized Medicine; Associate Professor, IUPUI School of Informatics, Indianapolis

JUNSHI CHEN, Senior Research Professor, Chinese Center for Disease Control and Prevention, Beijing

JANE HENNEY, Professor of Medicine, University of Cincinnati, Ohio

CARLOS M. MOREL, Director, Center for Technological Development in Health, Oswaldo Cruz Foundation (Fiocruz), Rio de Janeiro, Brazil

CLARE NARROD, Research Scientist and Risk Analysis Program Manager, University of Maryland, Joint Institute for Food Safety and Applied Nutrition, College Park

ANDY STERGACHIS, Professor, Departments of Epidemiology and Global Health; Adjunct Professor, Departments of Pharmacy and Health Sciences; Director, Global Medicines Program, School of Public Health, University of Washington, Seattle

PRASHANT YADAV, Director, Healthcare Research, William Davidson Institute, University of Michigan, Ann Arbor

Consultants

HOWARD A. ZUCKER, Pediatric Cardiac Anesthesiologist, Albert Einstein College of Medicine; Senior Advisor, Division of Global Health and Human Rights, Massachusetts General Hospital

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

NOEL GREIS, Director, Center for Logistics and Digital Strategy; Co-Director, UNC-Tsinghua Center for Logistics and Enterprise Development, Kenan Institute of Private Enterprise, Kenan-Flagler Business School, University of North Carolina at Chapel Hill

Staff

GILLIAN BUCKLEY, Program Officer, Study Director

PATRICIA CUFF, Senior Program Officer

ANNE CLAIBORNE, Senior Program Officer

KENISHA PETERS, Research Associate

RACHEL TAYLOR, Research Associate

MEGAN GINIVAN, Research Assistant

KATHLEEN BURNS, Intern (January-February 2012)

GAELAN RITTER, Intern (January-May 2011)

ELIZABETH WELLS, Intern (June-August 2011)

YING ZHANG, Intern (December 2010-December 2011)

JULIE WILTSHIRE, Financial Associate

PATRICK W. KELLEY, Director, Boards on Global Health and African Science Academy Development

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Reviewers

This report has been reviewed in draft form by individuals chosen for their diverse perspectives and technical expertise, in accordance with procedures approved by the National Research Council’s Report Review Committee. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for 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 wish to thank the following individuals for their review of this report:

Bonnie Buntain, University of Calgary, Faculty of Veterinary Medicine

Stephen R. Byrn, Purdue University, Department of Industrial and Physical Pharmacy

Chi-Wan Chen, Pfizer Inc., Global CMC

Cyprian Devine-Perez, New York University, Langone Medical Center

Linda Dimitropoulos, RTI International

David Fidler, Indiana University Maurer School of Law

Katherine A. High, University of Pennsylvania School of Medicine, Howard Hughes Medical Institute; Center for Cellular and Molecular Therapeutics, The Children’s Hospital of Philadelphia

Ann Marie Kimball, Bill & Melinda Gates Foundation

John E. Lamb, Abt Associates Inc., International Economic Growth Division

Glenn Morris, University of Florida, Emerging Pathogens Institute

Page viii Cite
Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Donald W. Schaffner, Rutgers, the State University of New Jersey, Department of Food Science

Christine L. Taylor, National Institutes of Health, Office of Dietary Supplements

Liz Wagstrom, National Pork Producers Council

Richard Whiting, Exponent, Inc., Chemical Regulation and Food Safety Center

Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the conclusions or recommendations, nor did they see the final draft of the report before its release. The review of this report was overseen by Marla E. Salmon, Dean and Professor, School of Nursing, University of Washington; and Johanna T. Dwyer, Professor, School of Medicine and Friedman School of Nutrition Science & Policy, Tufts University. Appointed by the National Research Council and the Institute of Medicine, they were responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authoring committee and the institution.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Foreword

A very high proportion of the seafood we eat comes from abroad, mainly from China and Southeast Asia. Most of the active ingredients in medicines we take originate in other countries. A substantial share of the produce we consume is grown in Latin America. 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. 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 to public awareness. Beyond manufacturing shortcuts, substitutes, and errors, the American food and drug supply can be a potential means for intentional harm, and the risk of terrorism intensifies the need for high levels of interagency collaboration across the FDA, Centers for Disease Control and Prevention, Department of Agriculture, and Department of Homeland Security.

Domestic programs, however, regardless of how well they are coordinated, will not be sufficient for the task. The integrated global economy demands cooperation across borders—to thwart terrorists, reduce environmental hazards, and ensure that our food and medical products are safe and effective. This requires coordination across both industrialized trading partners and emerging economies that have not had the benefit of decades of legal and technical development to ensure the safety of food and medical products.

The Institute of Medicine Committee on Strengthening Core Elements of Food and Drug Regulatory Systems in Developing Countries took up

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

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. This report describes 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. The committee’s report emphasizes an array of practical approaches to ensure sound regulatory practices in today’s interconnected world.

I am very grateful to the committee and to the staff who developed this report and hope that the insights, ideas, and recommendations offered here will enable residents in the United States and in other countries to benefit from safer food and medicine.

Harvey V. Fineberg, M.D., Ph.D.
President, Institute of Medicine

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

Acknowledgments

This report is a product of the cooperation and contributions of many people. The committee and staff are especially grateful to Anton Bandy, Jim Banihashemi, Laura DeStefano, Sarah Ziegenhorn, Vilija Teel, and Joel Wu of the Institute of Medicine (IOM). We also thank Linda Meyers and Maria Oria of the IOM Food and Nutrition Board for their advice. We also appreciate the contributions Bill McLeod of the National Academies and Elisabeth Reese of the National Research Council made to this report.

The committee’s overseas workshops went smoothly thanks to the warm hospitality of the Chinese Academy of Engineering, especially Yuan Min; the University of São Paulo School of Public Health, especially Viviane Jaremcrusk, Helena Ribeiro, and Carolina Cavanha de Azeredo Santos; the Academy of Science of South Africa, especially Roseanne Diab, Lebo Makgae, Phakamile Truth Mngadi, and Nthabiseng Toale; and the Public Health Foundation of India, especially Ramanan Laxminarayan, Srinath Reddy, Geetha Ramesh, Sunita Ramesh, and Susmita Roy.

Hongtao Ren of the Chinese Embassy and Debapriya Dutta of the Indian Embassy helped the committee and staff plan their travel in China and India respectively. The following Food and Drug Administation (FDA) foreign staff also worked tirelessly to help the committee and IOM staff prepare for their overseas workshops: Beverly Corey, Dennis Doupnik, Zimei (Mandy) Fu, Christopher Hickey, WeiHua (Evid) Liu, Ana Maria Osorio, Bruce Ross, Brenda Uratani, and Lixia Wang.

Many people kindly introduced the IOM staff to key speakers. They are particularly grateful to Bob Baker, Dai Ellis, Michael Gropp, Mat Heyman, Paul Young, and Chen Zu.

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×

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: Elaine Alexander, Claudio Poblete Amaro, Deborah Autor, Vani Bhambri Arora, Sunil Bahl, K.A. Balaji, Shabir Banoo, Sarah Barber, Sameer Barde, Arthur Bird, Carl-Maria Bohny, Kate Bond, James Browder, Regina Brown, Irene Chan, Wen Chang, Philip Chen, Gary Cheng, Jiayi Cheng, Qian Cheng, Nicholas Crisp, Robert Crookes, Sanjay Dave, Raymonde De Vries, Jose Luis Di Fabio, Ke Ding, Jagdish Dore, Albinus D’Sa, Raymond Dugas, Peter Karim Ben Embarek, Ernesto Enriquez, Gao Fang, Gerd Fleischer, Bernadette Franco, Xiao Geng, Débora Germano, Marc Gilkey, Carlos Alberto Goulart, Zhai Peng Gui, Rosane Cuber Guimarães, Qingwu Guo, Margaret Hamburg, Moazzem Hossain, Yinglian Hu, Rong Xiao Hua, Dennis Hudson, Ekopimo Okon Ibia, Anil Jauhri, Ghazala Javed, Arun Jha, Ding Jianhua, Zhang Jinghua, Loveleen Johri, Abhay Kadam, Greg Kalbaugh, Jincheng Kang, Sangeeta Kaul, Bi Kexin, C.B. Kotak, Don Kraemer, Michael Kravchuk, Pramod Kumar, Celestine Kumire, Hector Lazaneo, Li Lei, Sun Lei, David Leishman, Henry Leng, Yu Li, Derick Litthauer, Benny Liu, Patrick Lukulay, Mac Lumpkin, Maeve Magner, Onika Vig Mahajan, Lebo Makgae, Daniel Matlala Malose, R.M. Mandlik, Karen Midthun, Yuan Min, Henri A. Minnaar, Bejon Misra, M. Mitra, Neeraj Mohan, Lauro Moretto, Sana Mostaghim, Guo Nan, Kirti Narsai, Margareth Ndomondo-Sigonda, Skhumbuzo Ngozwana, Thanh Nguyen, Sergio Nishioka, Sarah Olembo, Adriana Valenzuela Palma, Janardan Panday, Ana Marisa Cordero Peña, Michael S. Pepper, Sylvia Pereira, Xu Yan Ping, Teizhinha de Jeusus Andreolli Pinto, Manuel Neto Pinto, Ajay Pitre, Amanda Poldi, Devendra Prasad, Rajeev Raizada, Raquel Ramilo, Ailton José Rebelo, Mike Robach, Chen Rui, S.K. Saxena, Nirupa Sen, D.G. Shah, Zuo Shuyan, Sarah Simons, G.N. Singh, Jasvir Singh, Ritambhara Singh, Rajinder Sood, Renato Spindel, John T. Sproul, Nick Starke, Gavin Steel, Marco Antonio Stephano, Silvia Storpirtis, Wei Sun, Pramod Swaich, Marta Taniwaki, Asit Tripathy, Pieter Truter, Mary Lou Valdez, Tarun Vij, Amelia Villar, Tanya Vogt, Liz Wagstrom, Sun Wei, Raymond Wigenge, Haiyan Xu, Lily Xu, Guo Xueping, Alice Yang, Steve Yang, Zhang Yi, Ji Yingping, Ma Yong, Worasuda Yoongthong, Li Yu, Penggui Zai, Jainkang (Jack) Zhang, Libin Zhao, Qiang Zheng, and Janette Zhou.

The committee and staff thank the U.S. Food and Drug Administration for generously funding this study.

Page xiii Cite
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×

Acronyms and Abbreviations

ADR

adverse drug reaction

AFDO

Association of Food and Drug Officials

AMRH

African Medicines Regulatory Harmonization

Anvisa

National Health Surveillance Agency (Brazil)

AOAC

Association of Official Analytic Communities

APEC

Asia Pacific Economic Cooperation

APEDA

Agricultural and Processed Food Products Export Authority

API

active pharmaceutical ingredient

ASEAN

Association of Southeast Asian Nations

AUIBAR

African Union Interafrican Bureau for Animal Resources

   
BIO

Biotechnology Industry Organization

   
CDC

Centers for Disease Control and Prevention

CDSCO

Central Drugs Standard Control Organization (India)

CFSAN

Center for Food Safety and Applied Nutrition

COE

Centers of Excellence

CPSI

Center for Science in the Public Interest

CRADA

Cooperative Research and Development Agreement

   
DHS

Department of Homeland Security

DNA

deoxyribonucleic acid

DOE

Department of Energy

DOJ

Department of Justice

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
EDQM

European Directorate for the Quality of Medicines and Healthcare

EFSA

European Food Safety Authority

EIC

Export Inspection Council of India

EMA

European Medicines Agency

EPA

Environmental Protection Agency

EU

European Union

EURASFF

European Union’s Rapid Alert Systems for Food and Feed

   
FAO

Food and Agriculture Organization of the United Nations

FBI

Federal Bureau of Investigation

FDA

Food and Drug Administration

FIAE

Food Industry Association Executives

FICCI

Federation of Indian Chambers of Commerce and Industry

FSMA

FDA Food Safety Modernization Act

FSSAI

Food Safety and Standards Authority of India

   
G20

The Group of 20

GAO

Government Accountability Office

GAP

Good Agricultural Practices

GHTF

Global Harmonization Task Force

GIZ

Gesellschaft für Internationale Zusammenarbeit (Society for International Cooperation)

GMP

Good Manufacturing Practices

GPhA

Generic Pharmaceutical Association

   
HACCP

Hazard Analysis and Critical Control Points

HIV

human immunodeficiency virus

HPV

human papillomavirus

HS

Harmonized System Codes

   
IAEA

International Atomic Energy Agency

IANPHI

International Association of National Public Health Institutes

IBA

International Biopharmaceutical Association

ICDRA

International Conference of Drug Regulatory Authorities

ICH

International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use

ICMSF

International Commission on Microbiological Specifications for Food

IICA

Inter-American Institute for Cooperation on Agriculture

IPPC

International Plant Protection Convention

ISO

International Organisation for Standardization

Suggested Citation:"Front Matter." Institute of Medicine. 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press. doi: 10.17226/13296.
×
MCC

Medicines Control Council of South Africa

MDMA

Medical Device Manufacturers Association

MRA

Medicines Regulatory Authority

   
NEPAD

New Partnership for Africa’s Development

NMRA

National Medicines Regulatory Authority

   
OECD

Organisation for Economic Co-operation and Development

OIE

World Organisation for Animal Health

   
PAHO

Pan American Health Organization

PhRMA

Pharmaceutical Research and Manufacturers of America

PREDICT

Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting

   
SEAICRN

Southeast Asia Infectious Disease Clinical Research Network

SFDA

State Food and Drug Administration (China)

SIT

sterile insect technique

SPPA

Strategic Partnership Program Agroterrorism

SPS

Sanitary and Phytosanitary Measures

SPS

Strengthening Pharmaceutical Systems

SRA

stringent regulatory authority

   
TBT

Technical Barriers to Trade

TRIPS

trade-related aspects of intellectual property rights

   
UN

United Nations

UNICEF

United Nations Children’s Fund

UNIDO

United Nations Industrial Development Organization

USAID

United States Agency for International Development

USDA

United States Department of Agriculture

USP

United States Pharmacopeia

USTR

United States Trade Representative

   
WHO

World Health Organization

WTO

World Trade Organization

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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.

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