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Margaret A. Hamburg

FDA Compliance

Global Cooperation Helps Expand Safety Net

Encouraging collaboration between nations on common regulatory issues

Published: Monday, December 3, 2012 - 10:09

Every year, millions of products regulated by the Food and Drug Administration (FDA) flood into the United States from 150 countries. Ensuring these products are safe and effective can be daunting task. It was heartening for me to sign two cooperative arrangements with some of our international partners that will make this task a little easier. The arrangements also represent encouraging developments in the quest for a global safety net created through international cooperation.

One arrangement, a “Statement of Cooperation” with the FDA’s counterpart in Brazil, outlines procedures for enhanced collaboration between our nations on common regulatory issues. The arrangement is particularly critical at a time when Brazil is dramatically increasing its trade with the United States. Last year, the United States imported from Brazil products totaling $31.4 billion (both FDA-regulated and not regulated)—an increase of 126 percent since the year 2000.

The second arrangement, also a Statement of Cooperation, is between the FDA and our regulatory counterparts in Australia, Brazil, and Canada. The arrangement creates stronger regulatory oversight that is less burdensome for both industry and regulators as resources are pooled to cover a larger global array of medical device manufacturers.

I signed both arrangements while in Manaus, Brazil, in the heart of the Amazon River basin. The heads of counterpart regulatory agencies from around the world came together to collaborate on ways to help better ensure product safety in all countries—an approach we refer to as the global safety net—a particularly appropriate occasion for signing these two arrangements.

Top regulatory officials from four countries, meeting at a summit in Brazil, prepare to sign the Statement of Cooperation among their respective agencies. They are, left to right, Paul Glover, assistant deputy minister of Canada’s Health Products and Food Branch; Margaret A. Hamburg, M.D., commissioner of the U.S. Food and Drug Administration; John Sherritt, national manager of Australia’s Therapeutic Goods Administration; and Dirceau Barbano, director chairman of Brazil’s National Agency for Sanitary Vigilance.

The already difficult job of ensuring the safety of FDA-regulated products has grown exponentially due to two mega trends: the expansion of global trade, and increasingly sophisticated products creating the need for ever-greater expertise from regulators.

Our strategy is to create coalitions of regulators that bring together the best minds from around the world to work on the common goal of improving product safety and quality. As I outlined at the conference, we need to develop a strategy that moves us toward routine regulatory coherence and mutual reliance with our regulatory counterparts. While maintaining national sovereignty and individual agency decision-making responsibility, we can do much more to share regulatory information, strategies, and resources.

The arrangements signed in Brazil stand as concrete examples of the broader concepts discussed at the conference.

The arrangement between the FDA and regulatory agencies in Australia, Brazil, and Canada provides for the creation of a single audit program for medical-device quality management systems. The four countries, in accordance with their respective legal authorities, would develop a plan to audit, or inspect, a device facility, and then the other countries would utilize the regulatory findings.

The four countries also pledged to promote greater global alignment of regulatory approaches and technical requirements. Standardized oversight procedures will bring more consistency, predictability, and transparency to the regulatory process.

The broad arrangement between Brazil and the United States includes a number of provisions. Both countries will consider exchanging information collected during investigations or facility inspections. They will also identify research that supports the scientific basis for regulations and actions.

What is expected is increased understanding of each other’s regulatory systems and an opportunity to explore how to leverage each country’s resources to expand the safety net for both countries.

The arrangements and the conference are steps toward a future with better outcomes through global cooperation. I was pleased to be a part of it.


About The Author

Margaret A. Hamburg’s picture

Margaret A. Hamburg

Margaret A. Hamburg, M.D., is the commissioner of the U.S. Food and Drug Administration (FDA). The second woman to be nominated for this position, she is an experienced medical doctor, scientist, and public health executive. As the top official of the FDA, Hamburg is committed to strengthening programs and policies that enable the agency to carry out its mission to protect and promote the public health.