International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary

by Institute of Medicine, Board on Health Sciences Policy, Forum on Drug Discovery Development and Transition, et al.

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...

• Format: Paperback
• Language: English
• ISBN: 0309284791
• ISBN13: 9780309284790
• Release Date: November 2013
• Publisher: National Academies Press
• Length: 128 Pages