Skip to main content

Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators

View Cover

Prepublication

Regulating Medicines in a Globalized World

The Need for Increased Reliance Among Regulators (2019)
Purchase Options
Overview

Contributors

Description

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.

Topics

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.

Import this citation to:

Publication Info

160 pages | 6 x 9
ISBNs:
  • Prepublication: 978-0-309-66995-5
  • Paperback (forthcoming): 978-0-309-49863-0
DOI: https://doi.org/10.17226/25594
Contents
Resources
Rights

Copyright Information

The National Academies Press and the Transportation Research Board have partnered with Copyright Clearance Center to offer a variety of options for reusing our content. You may request permission to:

  • Republish or display in another publication, presentation, or other media
  • Use in print or electronic course materials and dissertations
  • Share electronically via secure intranet or extranet
  • And more

For most Academic and Educational uses no royalties will be charged although you are required to obtain a license and comply with the license terms and conditions.

Click here to obtain permission for Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators.

Translation and Other Rights

For information on how to request permission to translate our work and for any other rights related query please click here.

Copyright.com Customer Service

For questions about using the Copyright.com service, please contact:

Copyright Clearance Center
22 Rosewood Drive
Danvers, MA 01923
Tel (toll free): 855/239-3415 (select option 1)
E-mail: info@copyright.com
Web: https://www.copyright.com
Stats

Loading stats for Regulating Medicines in a Globalized World: The Need for Increased Reliance Among Regulators...