Skip to main content
Proceedings

VIEW LARGER COVER

The past several decades have been a time of rapid globalization in the development, manufacture, marketing, and distribution of medical products and technologies. Increasingly, research on the safety and effectiveness of new drugs is being conducted in countries with little experience in regulation of medical product development. Demand has been increasing for globally harmonized, science-based standards for the development and evaluation of the safety, quality, and efficacy of medical products. Consistency of such standards could improve the efficiency and clarity of the drug development and evaluation process and, ultimately, promote and enhance product quality and the public health.

To explore the need and prospects for greater international regulatory harmonization for drug development, the IOM Forum on Drug Discovery, Development, and Translation hosted a workshop on February 13-14, 2013. Discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards. This document summarizes the workshop.

Suggested Citation

Institute of Medicine. 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press. https://doi.org/10.17226/18324.

Import this citation to:

Publication Info

128 pages |  6 x 9 | 

ISBNs: 
  • Paperback:  978-0-309-28479-0
  • Ebook:  978-0-309-28482-0
DOI: https://doi.org/10.17226/18324

What is skim?

The Chapter Skim search tool presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter. You may select key terms to highlight them within pages of each chapter.

Copyright Information

The National Academies Press (NAP) has partnered with Copyright Clearance Center's Marketplace service to offer you a variety of options for reusing NAP content. Through Marketplace, you may request permission to reprint NAP content in another publication, course pack, secure website, or other media. Marketplace allows you to instantly obtain permission, pay related fees, and print a license directly from the NAP website. The complete terms and conditions of your reuse license can be found in the license agreement that will be made available to you during the online order process. To request permission through Marketplace you are required to create an account by filling out a simple online form. The following list describes license reuses offered by the NAP through Marketplace:

  • Republish text, tables, figures, or images in print
  • Post on a secure Intranet/Extranet website
  • Use in a PowerPoint Presentation
  • Distribute via CD-ROM
  • Photocopy

Click here to obtain permission for the above reuses. If you have questions or comments concerning the Marketplace service, please contact:

Marketplace Support
International +1.978.646.2600
US Toll Free +1.855.239.3415
E-mail: support@copyright.com
marketplace.copyright.com

To request permission to distribute a PDF, please contact our Customer Service Department at customer_service@nap.edu.

loading iconLoading stats for International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary...