Ensuring Safe Foods
and Medical Products
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
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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.
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Suggested citation: IOM (Institute of Medicine). 2012. Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad. Washington, DC: The National Academies Press.
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INSTITUTE OF MEDICINE
OF THE NATIONAL ACADEMIES
Advising the nation. Improving Health.
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.
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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.
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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
HOWARD A. ZUCKER, Pediatric Cardiac Anesthesiologist, Albert Einstein College of Medicine; Senior Advisor, Division of Global Health and Human Rights, Massachusetts General Hospital
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
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
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
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.
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
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
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.
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.
Acronyms and Abbreviations
adverse drug reaction
Association of Food and Drug Officials
African Medicines Regulatory Harmonization
National Health Surveillance Agency (Brazil)
Association of Official Analytic Communities
Asia Pacific Economic Cooperation
Agricultural and Processed Food Products Export Authority
active pharmaceutical ingredient
Association of Southeast Asian Nations
African Union Interafrican Bureau for Animal Resources
Biotechnology Industry Organization
Centers for Disease Control and Prevention
Central Drugs Standard Control Organization (India)
Center for Food Safety and Applied Nutrition
Centers of Excellence
Center for Science in the Public Interest
Cooperative Research and Development Agreement
Department of Homeland Security
Department of Energy
Department of Justice
European Directorate for the Quality of Medicines and Healthcare
European Food Safety Authority
Export Inspection Council of India
European Medicines Agency
Environmental Protection Agency
European Union’s Rapid Alert Systems for Food and Feed
Food and Agriculture Organization of the United Nations
Federal Bureau of Investigation
Food and Drug Administration
Food Industry Association Executives
Federation of Indian Chambers of Commerce and Industry
FDA Food Safety Modernization Act
Food Safety and Standards Authority of India
The Group of 20
Government Accountability Office
Good Agricultural Practices
Global Harmonization Task Force
Gesellschaft für Internationale Zusammenarbeit (Society for International Cooperation)
Good Manufacturing Practices
Generic Pharmaceutical Association
Hazard Analysis and Critical Control Points
human immunodeficiency virus
Harmonized System Codes
International Atomic Energy Agency
International Association of National Public Health Institutes
International Biopharmaceutical Association
International Conference of Drug Regulatory Authorities
International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use
International Commission on Microbiological Specifications for Food
Inter-American Institute for Cooperation on Agriculture
International Plant Protection Convention
International Organisation for Standardization
Medicines Control Council of South Africa
Medical Device Manufacturers Association
Medicines Regulatory Authority
New Partnership for Africa’s Development
National Medicines Regulatory Authority
Organisation for Economic Co-operation and Development
World Organisation for Animal Health
Pan American Health Organization
Pharmaceutical Research and Manufacturers of America
Predictive Risk-based Evaluation for Dynamic Import Compliance Targeting
Southeast Asia Infectious Disease Clinical Research Network
State Food and Drug Administration (China)
sterile insect technique
Strategic Partnership Program Agroterrorism
Sanitary and Phytosanitary Measures
Strengthening Pharmaceutical Systems
stringent regulatory authority
Technical Barriers to Trade
trade-related aspects of intellectual property rights
United Nations Children’s Fund
United Nations Industrial Development Organization
United States Agency for International Development
United States Department of Agriculture
United States Pharmacopeia
United States Trade Representative
World Health Organization
World Trade Organization
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