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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.
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Below is the uncorrected machine-read text of this chapter, intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text of each book. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.

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 PREPUBLICATION COPY: UNCORRECTED PROOFS

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-XXXXX-X International Standard Book Number-10: 0-309-XXXXX-X 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. PREPUBLICATION COPY: UNCORRECTED PROOFS

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. PREPUBLICATION COPY: UNCORRECTED PROOFS

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. PREPUBLICATION COPY: UNCORRECTED PROOFS

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 PREPUBLICATION COPY: UNCORRECTED PROOFS v

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 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. PREPUBLICATION COPY: UNCORRECTED PROOFS vii

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 Poras, 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 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 NEPAD 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 for the Food and Drug Administration for generously funding this project. PREPUBLICATION COPY: UNCORRECTED PROOFS ix

Contents ACRONYMS AND ABBREVIATIONS xv SUMMARY S-1 1 INTRODUCTION 1-1 The Committee’s Approach to its Charge, 1-4 Globalization and Regulatory Systems, 1-5 References, 1-14 2 REGULATORY SYSTEMS, GLOBAL HEALTH, AND DEVELOPEMENT 2-1 Continuing Progress in Health and Development, 2-6 Understanding the Regulatory Process, 2-8 References, 2-25 3 GLOBAL EFFORTS TO STRENGTHEN REGULATORY SYSTEMS 3-1 The Role of Aid, 3-1 The Role of Commerce, 3-18 Expanding the Evidence Base for Regulatory Policy, 3-23 References, 3-26 4 THE ROLE OF THE NATIONAL GOVERNMENT 4-1 Legal Protection, 4-1 References, 4-17 5 THE ROLE OF THE REGULATORY AGENCY 5-1 Strategies for Managing Risk, 5-1 The Risks of Informal Markets, 5-12 Cooperation at Various Levels, 5-17 References, 5-26 APPENDIXES A COMMITTEE MEMBER BIOGRAPHIES A-1 B MEETING AGENDAS B-1 C CALL FOR COMMENTS C-1 D PREVIOUS RECOMMENDATIONS D-1 PREPUBLICATION COPY: UNCORRECTED PROOFS xi

Boxes, Figures, and Tables BOXES 1-1 Statement of Task, 1-3 2-1 Essential Public Health Functions, 2-2 2-2 Principal Regulatory Functions for Medical Products, 2-9 2-3 Principal Regulatory Functions for Foods, 2-9 2-4 Attributes of Effective Regulatory Systems, 2-10 2-5 Steps in a Risk-Based Regulatory Process, 2-11 2-6 African Medicines Agency, 2-17 2-7 Listeria Outbreak in South Africa, 2-23 3-1 What Are Data Standards? 3-16 3-2 The USDA Global Branded Food Products Database, 3-17 3-3 Twiga Foods, 3-20 4-1 Elements of a Comprehensive Medicines Law, 4-3 4-2 An FAO Model Food Law, 4-4 4-3 Preventing Undue Influence in Regulatory Decisions, 4-6 4-4 Key Definitions, 4-12 5-1 Attributes of a Risk-Based System, 5-2 5-2 The Knowledge Hub for Clinical Trial Data Sharing, 5-5 5-3 Risk-Based Inspections, 5-7 5-4 Food Labeling and Child Obesity, 5-12 5-5 The Accredited Drug Dispensing Outlets in Tanzania, 5-15 FIGURES 1-1 Global food and medical product basic curriculum framework for food, feed, or medical product regulatory functions, 1-12 2-1 A conceptual framework of important groups in food and medicines regulation, 2- 14 2-2 Multinational medicines regulatory programs, results of the International Coalition of PREPUBLICATION COPY: UNCORRECTED PROOFS xiii

Medicines Regulatory Authorities’ 2014-2015 mapping exercise, 2-19 3-1 WHO Global Benchmarking Tool performance levels, 3-3 3-2 Spider web graph of a hypothetical agency’s performance with the Global Benchmarking Tool, 3-4 3-3 Structure of the Food Control Assessment Tool, 3-6 3-4 The OIE Performance of Veterinary Services Pathway, 3-7 3-5 Animal product safety capacity, performance of veterinary services assessment in 93 countries, 3-8 3-6 Average proportion of local manufacturing and importation of medicines and vaccines, 3-11 3-7 Measures used to assess the Centers of Excellence in Regulatory Science and Innovation’s research, 3-24 4-1 Distribution of world population across national income groups in 2000 (left) and 2015 (right), 4-7 4-2 Interactions between regulators and the executive level of government, 4-14 4-3 Stepwise approach to harmonization, 4-17 5-1 A continuum of tools for international regulatory cooperation, 5-18 5-2 Steps to implement reliance for medicines registration, 5-23 5-3 A regulatory value chain for medicines regulation, 5-24 TABLES S-1 Overview of report organization and recommendations by topic and intended actors, S-3 1-1 Product Safety Crises around the World, 1-1 2-1 Relationships between Regulatory Systems and the Sustainable Development Goals, 2-3 2-2 A Cross Section of Multinational Food Safety Programs, 2-20 4-1 Pros and Cons of Different Financing Streams, 4-10 4-2 Structure and Funding of a Sample of Regulatory Agencies, 4-15 5-1 Different Types of Public and Private Standards, 5-20 PREPUBLICATION COPY: UNCORRECTED PROOFS xiv

Acronyms and Abbreviations ACUS Administrative Conference of the United States ASEAN Association of Southeast Asian Nations AIDS Acquired Immunodeficiency Syndrome APEC Asia-Pacific Economic Corporation AUDA African Union Development Agency CDC U.S. Centers for Disease Control and Prevention CERC Crisis and Emergency Risk Communications DALY Disability-Adjusted Life Year EFSA European Food Safety Authority EMA European Medical Agency FAO Food and Agriculture Organization of the United Nations FDA US Food and Drug Administration FMO Netherlands Development Finance Company GAO U.S. Government Accountability Office GAP Good Agricultural Practices GBT Global Benchmarking Tool GDP Gross domestic product GFSI Global Food Safety Initiative GFSP Global Food Safety Partnership HAI Health Action International HLPE High Level Panel of Experts on Food Security and Nutrition of the Food and Agriculture Organization of the UN HHS U.S. Department of Health and Human Services HIV Human Immunodeficiency Virus ICDRA International Conference of Drug Regulatory Authorities IADB Inter-American Development Bank 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 IFPMA International Federation of Pharmaceutical Manufacturers and Associations IFPTI International Food Protection Training Institute IHME Institute for Health Metrics and Evaluation PREPUBLICATION COPY: UNCORRECTED PROOFS xv

ILRI International Livestock Research Institute ILSI International Life Sciences Institute IMDRF International Medical Device Regulators Forum IMF International Monetary Fund IOM Institute of Medicine Infosan International Food Safety Authorities Network IRPCV Italian Regional Pharmacovigilance Center of Veneto ISO International Standards Organization JIFSAN Joint Institute for Food Safety and Applied Nutrition NAFDAC National Agency for Food and Drug Administration and Control NASEM National Academies of Sciences, Engineering, and Medicine NCD Noncommunicable Disease NEPAD New Partnership for Africa’s Development NIH National Institutes of Health NRC National Research Council ODI Overseas Development Institute OECD Economic Cooperation and Development OIE World Organisation for Animal Health PAHO Pan American Health Organization PANDRH Pan American Network for Drug Regulatory Harmonization PEPFAR U.S. President’s Emergency Plan for AIDS Relief SADCAS Southern Africa Development Community Accreditation Service STDF Standards and Trade Development Facility UHC Universal Health Coverage UN United Nations UNIDO United Nations Industrial Development Organization UNODC United Nations Office on Drugs and Crime USAID U.S. Agency for International Development USDA U.S. Department of Agriculture WBG The World Bank Group WHA World Health Assembly WHO World Health Organization WTO World Trade Organization PREPUBLICATION COPY: UNCORRECTED PROOFS xiv

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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.

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