Description

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.

Contents

• THE NATIONAL ACADEMIES
• PLANNING COMMITTEE FOR THE WORKSHOP ON INTERNATIONAL REGULATORY HARMONIZATION AMID GLOBALIZATION OF BIOMEDICAL RESEARCH AND MEDICAL PRODUCT DEVELOPMENT
• FORUM ON DRUG DISCOVERY, DEVELOPMENT, AND TRANSLATION
• Reviewers
• Acronyms
• 1. Introduction
  • OPENING REMARKS
  • INTERNATIONAL HARMONIZATION: AN INDUSTRY PERSPECTIVE
  • INTERNATIONAL HARMONIZATION: A REGULATOR’S PERSPECTIVE
• 2. Principles and Definitional Considerations
  • THE TERMINOLOGY LANDSCAPE AND OPTIONS FOR REGULATORS
  • STANDARDS SETTINGS IN THE CONTEXT OF REGULATORY HARMONIZATION
• 3. Overview of the Current Global Regulatory Landscape
  • ICH
  • PANDRH
  • APEC MEMBER ECONOMIES
  • HARMONIZATION INITIATIVES IN AFRICA
• 4. Areas of Need for Harmonized Standards and Barriers to Progress in Addressing the Gaps
  • GAPS FROM THE REGULATOR’S PERSPECTIVE
  • GAPS FROM THE PERSPECTIVE OF NONGOVERNMENTAL ORGANIZATIONS, FOUNDATIONS, AND PRODUCT DEVELOPMENT PARTNERSHIPS
  • BREAKOUT SESSION REPORTS
• 5. Characteristics of Harmonized Regulations and Regulatory Structures
  • RADIATION SAFETY STANDARDS
  • REFLECTIONS ON THE EXPERIENCES OF WHO
• 6. Finding Solutions: Options and Systemic Approaches
  • LEGAL FRAMEWORK
  • COOPERATION AND COLLABORATION
  • MUTUAL TRUST AND RECOGNITION
  • CAPACITY BUILDING
  • BUSINESS CASE
  • TOP-LEVEL SUPPORT
  • META-HARMONIZATION
  • SUGGESTIONS FOR MOVING FORWARD
• 7. Tactics and Strategies for a Way Forward
  • KEY THEMES
  • SUGGESTED PATHS FORWARD
• References
• Appendix A Workshop Agenda
• Appendix B Participant Biographies

This activity was supported by contracts between the National Academy of Sciences and the Department of Health and Human Services (HHSN26300023 [Under Base #HHSN263201200074I] and Contract No. N01-OD-4-2139 TO #276; HHSF22301026T [Under Base #HHSF223200810020I]), AbbVie Inc., American Diabetes Association, American Society for Microbiology, Amgen Inc., Association of American Medical Colleges, AstraZeneca, Bristol-Myers Squibb, Burroughs Wellcome Fund, Celtic Therapeutics, LLLP, Critical Path Institute, Doris Duke Charitable Foundation, Eli Lilly and Company, FasterCures, Friends of Cancer Research, GlaxoSmithKline, Johnson & Johnson, March of Dimes Foundation, Merck & Co., Inc., Novartis Pharmaceuticals Corporation, Pfizer Inc., and Sanofi. The views presented in this publication do not necessarily reflect the views of the organizations or agencies that provided support for the activity.

Suggested citation:

IOM (Institute of Medicine). 2013. International Regulatory Harmonization Amid Globalization of Drug Development: Workshop Summary. Washington, DC: The National Academies Press.

NOTICE: The workshop that is the subject of this workshop summary was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.