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Title Regulating medicines in a globalized world : the need for increased reliance among regulators / Alastair J. Wood and Patricia Cuff, editors ; Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, Board on Global Health, Health and Medicine Division
Published Washington, DC : National Academies Press, 2020

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Description 1 online resource (1 PDF file (xx, 147 pages)) : illustrations
Series A consensus study report
Consensus study report.
Contents Intro -- FrontMatter -- Reviewers -- Acknowledgments -- Preface -- Contents -- Boxes, Figures, and Table -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 The Job of Medicines Regulators in Today's World -- 3 What Policy Makers Need to Know About Today's Regulatory Environment -- 4 Stakeholder Views of Recognition and Reliance -- 5 Removing Impediments and Facilitating Action for Greater Recognition and Reliance Among Regulatory Authorities -- 6 The Way Forward -- References -- Appendix A: Glossary -- Appendix B: Table of Mutual Recognition Agreements
Summary 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
Bibliography Includes bibliographical references
Notes Online resource; title from PDF title page (viewed July 10, 2020)
Subject Drugs -- Safety regulations
Drugs -- Testing -- Government policy
Drugs -- Side effects.
Medical policy.
Drug Evaluation -- legislation & jurisprudence
Government Regulation
Drug-Related Side Effects and Adverse Reactions
Health Policy
Internationality
Medical policy
Drugs -- Side effects
Drugs -- Safety regulations
Drugs -- Testing -- Government policy
United States
Form Electronic book
Author Wood, Alastair J. J., editor
Cuff, Patricia A., editor
National Academies of Sciences, Engineering, and Medicine (U.S.). Committee on Mutual Recognition Agreements and Reliance in the Regulation of Medicines, issuing body.
ISBN 9780309498647
0309498643
9780309498661
030949866X