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.

Contents

• The National Academies of SCIENCES • ENGINEERING • MEDICINE
• COMMITTEE ON MUTUAL RECOGNITION AGREEMENTS AND RELIANCE IN THE REGULATION OF MEDICINES
• Reviewers
• Acknowledgments
• Preface
• Acronyms and Abbreviations
• Summary
  • ROLE OF REGULATORY AUTHORITIES
  • RECOGNITION AND RELIANCE
  • UNDERSTANDING THE REGULATORY ENVIRONMENT
  • LEVERAGING KEY OPPORTUNITIES TO OVERCOME MEDICINES REGULATORY CHALLENGES
  • THE WAY FORWARD
• 1. Introduction
  • STUDY CONTEXT
  • CHARGE TO THE COMMITTEE
  • STUDY SCOPE AND APPROACH
  • ORGANIZATION OF THE REPORT
• 2. The Job of Medicines Regulators in Today's World
  • CORE FUNCTIONS OF REGULATORS AND REGULATORY AUTHORITIES
  • REGULATORS WORKING TOGETHER
  • RECOGNITION AND RELIANCE
  • COOPERATION AND COLLABORATION TOOLS OF REGULATORY AUTHORITIES
• 3. What Policy Makers Need to Know About Today's Regulatory Environment
  • OVERVIEW OF GOOD PRACTICES
  • PUBLIC HEALTH MANDATE
  • IMPEDIMENTS TO REGULATORY AUTHORITY RELIANCE
  • CHALLENGES TO RELIANCE BETWEEN REGULATORY AUTHORITIES IN A GLOBALIZED WORLD
• 4. Stakeholder Views of Recognition and Reliance
  • VIEWS OF STAKEHOLDERS
  • SYNTHESIZING THE CHALLENGES AND OPPORTUNITIES
• 5. Removing Impediments and Facilitating Action for Greater Recognition and Reliance Among Regulatory Authorities
  • MEDICINES REGULATION IN A GLOBALIZED WORLD
  • IMPROVING PUBLIC HEALTH THROUGH BETTER-DESIGNED MRAs
  • RESPONDING TO EVOLVING SCIENCE AND TECHNOLOGY
  • BETTER UTILIZATION OF THE EU-US MRA
  • FACILITATING INFORMATION SHARING AMONG INTERNATIONAL MEDICINES REGULATORS
  • EVALUATING PUBLIC HEALTH IMPACTS OF RECOGNITION AND RELIANCE ARRANGEMENTS FOR MEDICINES REGULATION
• 6. The Way Forward
  • PHARMACOVIGILANCE AND POST-MARKET SURVEILLANCE
  • AGGREGATE SAFETY REPORTS
  • EXPANDING MUTUAL RECOGNITION AGREEMENTS TO GO BEYOND GOOD MANUFACTURING PRACTICE
  • EVALUATING PUBLIC HEALTH IMPACTS OF RECOGNITION AND RELIANCE
  • FINAL THOUGHTS
• References
• Appendix A. Glossary
• Appendix B. Table of Mutual Recognition Agreements
• Appendix C. Table of Global Good Manufacturing Practice (GMP) Reliance Initiatives Based on the International Coalition of Medicines Regulatory Authorities' Mapping Exercise
• Appendix D. Study Methods
• Appendix E. Committee Member Biographies

Suggested citation:

National Academies of Sciences, Engineering, and Medicine. 2020. 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.

Digital Object Identifier: https://doi.org/10.17226/25594

Library of Congress Control Number: 2020930367

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.

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