Background and Meeting Objectives:
The last several decades have seen a rapid globalization of commerce, including within the medical product and technology sectors. Investigational studies for products intended for use in U.S. populations are increasingly being conducted outside the U.S., often in countries with limited regulatory capacity. Moreover, biopharmaceutical companies seeking global markets face requirements for regulatory submissions for the same product in numerous international jurisdictions that could introduce scientific requirements that are discordant with U.S. standards. Discordant data requirements could result in additional clinical trials and animal studies, exposing more patients to experimental drugs and increasing the use of laboratory animals. There is a need for globally harmonized, science-based standards for the development and evaluation of safety, quality, and efficacy of medical products – both to enhance the efficiency and clarity of the drug development and evaluation process, and ultimately to promote and enhance product quality and the public’s health. There is also need for harmonization of standards for ongoing safety and quality surveillance of marketed biomedical products.
The National Academies Forum on Drug Discovery, Development, and Translation hosted a public workshop on February 13-14, 2013. This public workshop addressed needs for international harmonization of regulatory standards to support the development, evaluation and surveillance of biomedical products. Specifically, the discussions at the workshop helped identify principles, potential approaches, and strategies to advance the development or evolution of more harmonized regulatory standards.
Planning Committee
Thomas J. Bollyky (Co-chair), Council on Foreign Relations
Steven K. Galson (Co-chair), Amgen, Inc.
Michael J. Brennan, Aeras Global TB Vaccine Foundation
Raymond Chua, Singapore Health Sciences Authority
Hans-Georg Eichler, European Medicines Agency
James Fitzgerald, Pan-American Health Organization
Lynn D. Hudson, Critial Path Institute
Andreas Seiter, World Bank
Alice Till, PhRMA
Mary Lou Valdez, FDA Office of International Programs
Janet Woodcock, FDA Center for Drug Evaluation and Research
Below are materials for the workshop, including an agenda and presentations.
For additional information on the workshop, including the planning committee and sponsors, please visit our project page. Video recordings of the meeting can be found here.