Impact of regulatory science on global public health.

Regulatory science plays a vital role in protecting and promoting global public health by providing the scientific basis for ensuring that food and medical products are safe, properly labeled, and effective. Regulatory science research was first developed for the determination of product safety in the early part of the 20th Century, and continues to support innovation of the processes needed for regulatory policy decisions. Historically, public health laws and regulations were enacted following public health tragedies, and often the research tools and techniques required to execute these laws lagged behind the public health needs. Throughout history, similar public health problems relating to food and pharmaceutical products have occurred in countries around the world, and have usually led to the development of equivalent solutions. For example, most countries require a demonstration of pharmaceutical safety and efficacy prior to marketing these products using approaches that are similar to those initiated in the United States. The globalization of food and medical products has created a shift in regulatory compliance such that gaps in food and medical product safety can generate international problems. Improvements in regulatory research can advance the regulatory paradigm toward a more preventative, proactive framework. These improvements will advance at a greater pace with international collaboration by providing additional resources and new perspectives for approaching and anticipating public health problems. The following is a review of how past public health disasters have shaped the current regulatory landscape, and where innovation can facilitate the shift from reactive policies to proactive policies.

Advancing global health through regulatory science research: summary of the Global Summit on Regulatory Science Research and Innovation.

As a first step in the implementation of the Food and Drug Administration's (FDA) Pathway to Global Product Safety and Quality (Anonymous, 2011), FDA's Office of International Programs (OIP) and the National Center for Toxicological Research (NCTR) sponsored a Global Summit on Regulatory Science Research and Innovation. Through a series of presentations and panel discussions, the Global Summit participants explored how research could be used more effectively as a tool for advancing regulatory science, food safety, medical technologies, and public health. Speakers provided an overview of each of the components in the global regulatory-science research initiative, including scientific innovation and modernizing toxicology; and discussed how the integration of these components is needed to achieve the promise of regulatory science at the global level. All participants agreed with the formation of a Global Coalition of Regulatory Research Scientists who will work collaboratively to build knowledge, promote the development of regulatory science, discover novel ways to clearly define research needs, and improve public health.