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Margaret A. Hamburg

FDA Compliance

World Health Assembly 2014

Joining forces to strengthen regulatory systems globally

Published: Tuesday, June 17, 2014 - 13:46

The World Health Assembly is the decision-making body of the World Health Organization (WHO), attended every year by leading government health officials from its 194 member nations. Recently, I was pleased to participate as a member of the U.S. delegation in the 67th meeting of this important group in Geneva.

One of the key topics addressed during this year’s assembly was the critical role played by regulatory systems to ensure the safety, quality, and efficacy of medical products. Resolutions addressed the need to monitor and act on the rise in antimicrobial resistance, strengthen regulatory systems, and enhance access to biotherapeutic products.

As part of the resolution on antimicrobial resistance, the WHO will develop a draft global action plan to combat this problem. Member states were urged to strengthen their drug management systems, support research to extend the lifespan of existing drugs, and encourage the development of new diagnostics and treatment options.

The passage of a resolution to strengthen regulatory systems is itself a milestone for global health. It endorses a comprehensive approach to strengthening medical product regulation, and represents a basic change from traditional capacity-building that has focused primarily on sharing technical expertise. The new systems-oriented approach embraces the need for a strong legal framework, and the use of data and information technology, leadership, governance, partnership, and sustainable financing to strengthen regulatory effectiveness and efficiency.


Commissioner Margaret Hamburg speaks at the World Health Assembly

The adoption of this resolution, co-sponsored by Australia, Brazil, Colombia, Mexico, Nigeria, South Africa, Thailand, and the United States, demonstrates a true international partnership across regions, with many nations affirming their commitment to working individually and together to strengthen their regulatory systems. This is the only way governments and their regulatory authorities can continue to build a global product safety net that will benefit patients and consumers around the world.

During the assembly, I had the privilege of co-hosting a special session entitled, "Regulatory Systems Strengthening: Mobilizing People and Resources" with the Mexican Secretary of Health, Dr. Mercedes Juan Lopez. The distinguished panel included Malebona Precious Matsoso, director general for the Department of Health in South Africa; Dr. Mark Dybul, executive director for The Global Fund to Fight AIDS, Tuberculosis and Malaria; Dr. Marie-Paule Kieny, assistant director-general for the World Health Organization; and Dr. Vincent Ahonkhai, the senior regulatory officer of the Bill and Melinda Gates Foundation. The discussions focused on several important themes, including the multiple benefits of strong regulatory systems for the public health, national security, and economic development and investment.

The panelists highlighted the unique challenges and opportunities faced by regulators because of globalization and the extraordinary increase in the global supply of medical products, and the high cost of regulatory system failures to patients and their trust in the health system. More specifically, the discussions focused on the critical role that regulators play in ensuring access to lifesaving medical products by creating an environment of good regulatory practices that support innovation and research, and protect the public from threats resulting from substandard or counterfeit products.

Panelists also reported on progress that is being made as nations increasingly collaborate to share information, reduce inefficiencies, and work toward regulatory convergence. For example, participants learned about the World Health Organization’s decades-long efforts to support countries in strengthening their systems, and about WHO's prequalification program to ensure that select priority essential medicines, diagnostics, and vaccines are of high quality, safety, and efficacy for international procurement agencies and developing countries with limited regulatory capacity.

These kinds of collaborative strategies are essential in this global age. Only by strengthening our international partnerships, and by building regulatory systems that work together and support each other, can we ensure the quality, safety and efficacy of the medical products that the citizens of our nations depend upon.

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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.