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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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Suggested Citation:"Front Matter." National Academies of Sciences, Engineering, and Medicine. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. doi: 10.17226/25594.
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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.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators Alastair Wood, Patricia Cuff, Editors Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines Board on Global Health Health and Medicine Division 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 a contract between the National Academy of Sciences and the U.S. Food and Drug Administration’s Office of International Programs (HHSP233201400020B). 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/10.17226/25594 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 2019 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. 2019. Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators. Washington, DC: The National Academies Press. https://doi.org/10.17226/25594. 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 MUTUAL RECOGNITION AGREEMENTS AND RELIANCE IN THE REGULATION OF MEDICINES ALASTAIR J. J. WOOD (Chair), Professor of Medicine (Emeritus), Professor of Pharmacology (Emeritus), Vanderbilt University DAVID BEIER, Managing Director, Bay City Capital THOMAS BOLLYKY, Director, Global Health Program, Council on Foreign Relations KATHERINE BOND, Vice President, International Public Policy and Regulatory Affairs, US Pharmacopeia MARTHA BRUMFIELD, President and Chief Executive Officer, Critical Path Institute DAVID COCKBURN, Head of Manufacturing and Quality Compliance (Retired), European Medicines Agency ELIZABETH GOLBERG, Senior Fellow, Harvard Kennedy School LAWRENCE GOSTIN, Linda & Timothy O’Neill Professor of Global Health Law, Georgetown University GAVIN HUNTLEY-FENNER, Human Factors and Safety Consultant, Huntley-Fenner Advisors, Inc. BARBARA KOREMENOS, Professor, University of Michigan MURRAY LUMPKIN, Deputy Director, Integrated Delivery, Lead for Global Regulatory Systems Initiatives, Bill & Melinda Gates Foundation LEMBIT RÄGO, Secretary-General, Council for International Organizations of Medical Sciences Study Staff PATRICIA CUFF, Study Director (from April 2019), Senior Program Officer MONICA WHITLEY, Study Director (until August 2019) DANIEL FLYNN, Research Associate INEZ ADAMS, Research Assistant KELLY CHOI, Senior Program Assistant (from April 2019) NATALIE LUBIN, Senior Program Assistant (until April 2019) JULIE PAVLIN, Director, Board on Global Health Consultants RONA BRIERE, Editor PATRICIA CUFF, Editor ALASTAIR WOOD, Editor 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. The committee thanks the following individuals for their review of this report: Robert Califf, Duke University Emer Cooke, World Health Organization Petra Doerr, Petra Doerr Consulting Ltd. Martin Harvey-Allchurch, Unitaid Geneva Paul Huckle, GlaxoSmithKline (retired) Ian Hudson, Medicines and Healthcare products Regulatory Agency Raj Long, Bill & Melinda Gates Foundation Toshiyoshi Tominaga, Japan Self-Medication Industry 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 Joshua M. Sharfstein, Johns Hopkins Bloomberg School of Public Health, and William M. Sage, The University of Texas at Austin. 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 During the course of the year-long study, the committee invited key participants from different countries to share their insights at open committee meetings and information gathering sessions. This report would not have been possible without their important contributions. The committee would like to take this opportunity to thank all those who gave generously of their time, knowledge, experiences, and resources (see Appendix D). In particular, the committee would like to thank the Bill & Melinda Gates Foundation that supported the committee’s information gathering session in London; and the US FDA for sponsoring this study, with special thanks to Mark Abdoo, Russell Campbell, and Mary Lou Valdez. The committee would be remiss if acknowledgement was not given to the National Academies staff with administrative assistance from Kelly Choi and Natalie Lubin, research help from Daniel Flynn and Inez Adams, oversight from Julie Pavlin and Monica Whitley, and overall study coordination and direction from Patricia Cuff. There is similar appreciation going to the talented editing staff headed by Rona Briere and supported by Alisa Decatur. It is through the participation of all these valued stakeholders that the committee presents the study report stemming from the input and efforts of everyone involved. PREPUBLICATION COPY: UNCORRECTED PROOFS ix

Preface Globalization is now an integral part of all of our lives. We routinely expect to be able to perform many aspects of our everyday activities no matter where we are. We step off an international flight in some far-flung destination and expect to instantly use our cell phone, order a ride hailing service, pay for a hotel with our credit card, access our electronic documents held on a distant server, and even withdraw cash from our local bank account while traveling to faraway lands. Just as our lives have been touched by the power of globalization, so too has the pharmaceutical industry. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines now being global commodities. Drug companies operate in many parts of the world, utilize global supply chains that often include facilities in countries with weaker regulations than those of the United States, perform pivotal trials in multiple countries to support registration submissions in multiple jurisdictions and subsequently market their medicines throughout most of the world. However, they are then regulated by individual national regulators each of which requires submissions for review prior to marketing authorization. Each review procedure requires resources on the part of the sponsor and of the regulatory authorities and often there is little acknowledgment that a similar product review is occurring, sometimes simultaneously, in several other countries. All of these national regulators have the mission of with ensuring that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. The standards for such safety, efficacy, and quality judgments amongst the major well-resourced regulators (U.S. Food and Drug Administration [FDA], the European Medicines Agency [EMA], the Pharmaceuticals and Medical Devices Agency, Japan [PMDA], Health Canada, the Medicines and Healthcare products Regulatory Agency, UK [MHRA], Swissmedic, and the Therapeutic Goods Administration [TGA]) are well known and similar, if not identical. Although the final judgment on whether to approve a drug for marketing is an important sovereign decision for each national regulator to make, based on, what is appropriate and what level of risk tolerance exists in a given society, in some cases much of the work that forms the scientific basis for the authorization decision is quite similar, if not identical across the various regulators. The result is considerable duplicative and redundant work being performed throughout the world, which benefits neither national or global public health. For example, having multiple regulators inspecting the same manufacturing site has little value and in fact may compromise public health because the time might better be devoted to inspecting different sites and therefore ensuring the safety of a larger spectrum of manufacturing sites. Clearly if different versions of a product are PREPUBLICATION COPY: UNCORRECTED PROOFS xi

manufactured by the same company at different sites for different markets, inspections of the different sites are required. Similarly, multiple detailed reviews of exactly the same data by multiple national reviewers are unlikely to improve our knowledge of the product or patient outcomes. In this context, the purpose of this FDA-requested study was for an expert committee convened by the National Academies of Sciences, Engineering, and Medicine to consider the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. Through its conversations with various key stakeholders, the committee came to recognize that two very different roles exist for national regulators in relation to reliance activities. First, there is the potential for horizontal reliance activities among well-resourced regulators who share similar regulatory and scientific skill sets, as well as regulatory and structural similarities, that can more easily give way to mutual confidence and bidirectional reliance. It was within such reliance activities that committee members saw opportunities for more effective public health protection by improving and expanding the potential for relying upon the work of other similar regulatory authorities for making informed decisions. Additional opportunities for leveraging reliance activities more broadly have the potential to impact public health globally. This was the concept envisioned by members of the committee, who proposed greater access by less resourced regulators to the regulatory work products (e.g., inspection reports, scientific assessments) of well-resourced regulators. In this way, less- resourced regulators would be better positioned to make informed sovereign regulatory decisions, while using their own finite resources in the most efficient manner. Reliance in these scenarios might be unidirectional, but at present such reliance often is not possible because of the unwillingness or inability of some national regulators to share unredacted or less-redacted work products. Lack of access to such work products has direct negative impacts on the global health of millions of patients, especially those outside of Europe, North America, and Oceania. The committee also recognized that as medicines, such as biologicals and biosimilars, become increasingly more complex and as cell based and genetic therapies become more widespread, only a limited number of national regulators will be able to deploy the full range of skills necessary for comprehensive reviews of such products. Thus, it becomes imperative that reviews of complex medicines be made available to other regulators so that they can provide appropriate oversight of these products in their jurisdictions. Addressing these challenges is a high priority for global health and is one that requires the attention of both national regulators and legislators to facilitate the ability of others to use the work products of well-resourced regulators. The committee considered the opportunities that increased reliance activities by regulatory authorities might provide to the national and global public health but also considered the practical difficulties of implementing such reliance activities. Global regulators have been working diligently in the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) and other fora to develop and agree upon harmonized technical standards for the registration of medicines. Like so many of the things we now take for granted that function seamlessly across national frontiers, there are opportunities for improvements in medicines regulation that could enhance global health. However, it is worth emphasizing that the committee did not see this exercise as necessarily being one that would reduce costs, but rather one that could enhance public health by allowing the most efficient deployment of scarce and precious global regulatory resources. PREPUBLICATION COPY: UNCORRECTED PROOFS xii

Contents ACRONYMS AND ABBREVIATIONS xvii SUMMARY 1 Role of Regulatory Authorities, 2 Recognition and Reliance, 3 Understanding the Regulatory Environment, 4 Leveraging Key Opportunities to Overcome Medicines Regulatory Challenges, 5 The Way Forward, 11 1 INTRODUCTION 13 Study Context, 14 Charge to the Committee, 16 Study Scope and Approach, 17 Organization of the Report, 17 2 THE JOB OF MEDICINES REGULATORS IN TODAY’S WORLD 19 Core Functions of Regulators and Regulatory Authorities, 19 Regulators Working Together, 20 Recognition and Reliance, 21 Cooperation and Collaboration Tools of Regulatory Authorities, 24 3 WHAT POLICY MAKERS NEED TO KNOW ABOUT TODAY’S REGULATORY ENVIRONMENT 29 Good Practices, 30 Public Health Mandate, 36 Impediments to Regulatory Authority Reliance, 37 Challenges to Regulatory Authority Reliance in a Globalized World, 39 4 STAKEHOLDER VIEWS OF RECOGNITION AND RELIANCE 43 Views of Stakeholders, 43 Synthesizing the Challenges and Opportunities, 51 PREPUBLICATION COPY: UNCORRECTED PROOFS xiii

xiv REGULATING MEDICINES IN A GLOBALIZED WORLD 5 REMOVING IMPEDIMENTS AND FACILITATING ACTION FOR GREATER RECOGNITION AND RELIANCE AMONG REGULATORY AUTHORITIES 53 Medicines Regulation in a Globalized World, 54 Improving Public Health Through Better-Designed MRAs, 58 Responding to Evolving Science and Technology, 59 Better Utilization of the EU-US MRA, 60 Facilitating Information Sharing Among International Medicines Regulators, 62 Evaluating Public Health Impacts of Reliance and Recognition Arrangements for Medicines Regulation, 65 6 THE WAY FORWARD 69 Final Thoughts, 72 REFERENCES 75 APPENDIXES A GLOSSARY A-1 B TABLEOF BI-LATERAL MUTUAL RECOGNITION AGREEMENTS B-1 C TABLE OF GLOBAL RELIANCE INITIATIVES BASED ON ICMRA’S MAPPING EXERCISE C-1 D STUDY APPROACH AND METHODS D-1 E COMMITTEE MEMBER BIOGRAPHIES E-1 PREPUBLICATION COPY: UNCORRECTED PROOFS

Boxes, Figures, and Table BOXES 1-1 Statement of Task, 16 2-1 WHO Definitions of Recognition and Reliance, 21 2-2 Work-Sharing: Australia, Canada, Switzerland, Singapore (ACSS) Consortium, 25 2-3 Representative Multilateral, International Cooperative & Collaborative Efforts Within Pharmaceutical Regulation, 27 3-1 Batch Release, 34 3-2 Summary of the International API Inspection Program Evaluation, 41 4-1 Impediments to International Communication and Collaboration, 44 4-2 Challenges Within Regulatory Reliance, 44 4-3 Benefits and Perceived Benefits of Reliance in Medicines Approval Decisions, 46 4-4 Benefits of International Communication and Collaboration, 46 4-5 Perceived Benefits of Reliance in GMP Inspections, 47 4-6 Opportunities within Reliance on GMP Inspections, as well as Other Areas, 49 FIGURES S-1 Lifecycle of a medicine, 3 S-2 Building confidence and trust from and for greater reliance, 5 1-1 Building confidence and trust from and for greater reliance, 15 2-1 Recognition as a subset of reliance, 22 2-2 Trust components needed for reliance, 24 3-1 The complex drug landscape, 30 3-2 Lifecycle of a medicine, 31 PREPUBLICATION COPY: UNCORRECTED PROOFS xv

xvi REGULATING MEDICINES IN A GLOBALIZED WORLD TABLE 3-1 Comparison of MRAs (see Appendix A for a fuller description), 32 PREPUBLICATION COPY: UNCORRECTED PROOFS

Acronyms and Abbreviations ACSS Australia-Canada-Singapore-Switzerland Consortium ANVISA National Sanitary Surveillance Agency (Brazil) API active pharmaceutical ingredient ASEAN Association of Southeast Asian Nations BE bioequivalence CC Confidentiality Commitment CECMED Centro para el Control Estatal de Medicamentos, Equipos y Dispositivos Médicos (Cuba) COFEPRIS Federal Commission for the Protection against Sanitary Risk (Mexico) COR comparable overseas regulator CPP certificate of a pharmaceutical product CSR clinical study report CTD Common Technical Document EEA European Economic Area EMA European Medicines Agency EU European Union FDA Food and Drug Administration (US) GAO Government Accountability Office GCP good clinical practice GDP good distribution practice GLP good laboratory practice GMDP good manufacturing and good distribution practice GMP good manufacturing practice HC Health Canada HSA Health Sciences Authority (Singapore) PPREPUBLICATION COPY: UNCORRECTED PROOFS xvii

xviii REGULATING MEDICINES IN A GLOBALIZED WORLD ICDRA International Conference of Drug Regulatory Authorities ICH International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use ICMRA International Coalition of Medicines Regulatory Authorities IPRF International Pharmaceutical Regulators Forum IPRP International Pharmaceutical Regulators Program MA marketing authorization MHRA Medicines and Healthcare products Regulatory Agency (UK) MHWL Ministry of Health, Labour and Welfare (Japan) MRA Mutual Recognition Agreement NBCD non-biological complex drug NCE new chemical entity PE pharmaceutical equivalence PIC/S PIC/S Pharmaceutical Inspections Cooperation Scheme PMDA Pharmaceuticals and Medical Devices Agency (Japan) RA regulatory authority TFDA (CT) Taiwan Food and Drug Administration TGA Therapeutic Goods Administration of Australia TITCK Turkish Medicines and Medical Devices Agency UK United Kingdom VICH International Cooperation on Harmonisation for Registration of Veterinary Medicinal Products WHO World Health Organization PREPUBLICATION COPY: UNCORRECTED PROOFS

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Globalization is rapidly changing lives and industries around the world. Drug development, authorization, and regulatory supervision have become international endeavors, with most medicines becoming global commodities. Drug companies utilize global supply chains that often include facilities in countries with inconsistent regulations from those of the United States, perform pivotal trials in multiple countries to support registration submissions in various jurisdictions, and subsequently market their medicines throughout most of the world. These companies operate across borders and require individual national regulators to ensure that drugs authorized for use in their countries are safe and effective, and appropriate for their health care system and their population. This process involves significant resources and often duplicative work. It is important to consider how this process can be improved in order to better allocate resources, time, and efforts to improve public health.

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators considers the role of mutual recognition and other reliance activities among regulators in contributing to enhancing public health. This report identifies opportunities for leveraging reliance activities more broadly in order to potentially impact public health globally. Key topics in this report include the job of medicines regulators in today’s world, what policy makers need to know about today’s regulatory environment, stakeholder views of recognition and reliance, as well as removing impediments and facilitating action for greater recognition and reliance among regulatory authorities.

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