International Regulatory Harmonization Amid Globalization of Drug Development : Workshop Summary

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. Table of ContentsFront Matter1 Introduction2 Principles and Definitional Considerations3 Overview of the Current Global Regulatory Landscape4 Areas of Need for Harmonized Standards and Barriers to Progressin Addressing the Gaps5 Characteristics of Harmonized Regulations and RegulatoryStructures6 Finding Solutions: Options and Systemic Approaches7 Tactics and Strategies for a Way ForwardReferencesAppendix A: Workshop AgendaAppendix B: Participant Biographies