FOOD AND DRUG REGULATORY
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
THE NATIONAL ACADEMIES PRESS
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.
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.
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.
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
This page intentionally left blank.
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.
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
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.
The Committee’s Approach to Its Charge
Globalization and Regulatory Systems
2 REGULATORY SYSTEMS, GLOBAL HEALTH, AND DEVELOPMENT
Continuing Progress in Health and Development
Understanding the Regulatory Process
3 GLOBAL EFFORTS TO STRENGTHEN REGULATORY SYSTEMS
Expanding the Evidence Base for Regulatory Policy
4 THE ROLE OF THE NATIONAL GOVERNMENT
5 THE ROLE OF THE REGULATORY AGENCY
A COMMITTEE MEMBER BIOGRAPHIES
D ENSURING SAFE FOODS AND MEDICAL PRODUCTS THROUGH STRONGER REGULATORY SYSTEMS ABROAD
Boxes, Figures, and Tables
2-1 Essential Public Health Functions
2-2 Principal Regulatory Functions for Medical Products
2-3 Principal Regulatory Functions for Foods
2-4 Attributes of Effective Regulatory Systems
2-5 Steps in a Risk-Based Regulatory Process
2-7 Listeria Outbreak in South Africa
3-2 The USDA Global Branded Food Products Database
4-1 Elements of a Comprehensive Medicines Law
4-3 Preventing Undue Influence in Regulatory Decisions
5-1 Attributes of a Risk-Based System
5-2 The Knowledge Hub for Clinical Trial Data Sharing
5-4 Food Labeling and Child Obesity
5-5 The Accredited Drug Dispensing Outlets in Tanzania
D-1 Statement of Task from the 2012 Report
D-2 Essential Elements of Food and Medical Product Regulatory Systems
1-1 Global food and medical product basic curriculum framework for food, feed, or medical product regulatory functions
2-1 A conceptual framework of important groups in food and medicines regulation
2-2 Multinational medicines regulatory programs, results of the International Coalition of Medicines Regulatory Authorities’ 2014–2015 mapping exercise
3-1 WHO Global Benchmarking Tool performance levels
3-2 Spider web graph of a hypothetical agency’s performance with the Global Benchmarking Tool
3-3 Structure of the Food Control Assessment Tool
3-4 The OIE Performance of Veterinary Services Pathway
3-5 Animal product safety capacity, performance of veterinary services assessment in 93 countries
3-6 Average proportion of local manufacturing and importation of medicines and vaccines
3-7 Measures used to assess the Centers of Excellence in Regulatory Science and Innovation’s research
4-1 Distribution of world population across national income groups in 2000 and 2015
4-2 Interactions between regulators and the executive level of government
4-3 Stepwise approach to harmonization
5-1 A continuum of tools for international regulatory cooperation
5-2 Steps to implement reliance for medicines registration
S-1 Overview of Report Organization and Recommendations by Topic and Intended Actors
1-1 Product Safety Crises Around the World
2-1 Relationships Between Regulatory Systems and the Sustainable Development Goals
2-2 A Cross-Section of Multinational Food Safety Programs
4-1 Pros and Cons of Different Financing Streams
4-2 Structure and Funding of a Sample of Regulatory Agencies
5-1 Different Types of Public and Private Standards
D-1 Recommendations from the 2012 Report
This page intentionally left blank.
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|
|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|
|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|
|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|