Regulating Medicines in a Globalized World

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.

Table of Contents

• Front Matter
• 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
• 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
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