FDA Fact Sheet: Increasing FDA Capacity in China

Fundamental changes in our economic and security landscape require the U.S. Food and Drug Administration (FDA) to change its regulatory approaches to promote and protect the health of the American people. Over the past decade, the global economy has been shaped by a number of forces, including rapidly increasing flows of goods into the United States. It is expected that eventually, the growth in imports of FDA-regulated products will outpace the growth of domestic production. According to some estimates, imports of FDA-regulated products may triple between 2007 and 2015, corresponding to a 15 percent annual growth rate. Companies will not only be producing more FDA-regulated products abroad, but these products will follow complex paths through multi-step supply chains to reach the U.S.

Nowhere is this dynamic more evident than in U.S. trade with China. From October 1, 2006 to September 30, 2011 – during the Fiscal Years (FYs) 2007-2011 – the total number of shipments of FDA-regulated products from China increased approximately from 1.3 million to 2.1 million. Of the 2.1 million entry lines arriving in FY 2011, 30 percent were drugs and devices, and 12 percent were human food products.

New Approach and Resources

To protect American consumers by ensuring that these rapidly increasing Chinese imports are safe, effective, and comply with U.S. science-based standards, FDA must adopt a new regulatory approach: it must increase its capacity for inspecting and analyzing Chinese products before they are shipped to the United States.

In his budget proposal for FY 2013, the President supports this approach by adding $10 million to FDA’s budget base. If appropriated by Congress, these new resources will strengthen the protection of American consumers and patients in the following ways:

• FDA will strengthen its inspection and analytical capabilities by increasing its presence in China by sixteen inspectors and by adding three U.S.-based China analysts.
   
• FDA will broaden the range of its inspections. In addition to inspecting Chinese facilities that manufacture food and medical products for export to the United States, FDA will inspect sites of clinical trials and conduct follow-up inspections to ensure that firms continue to produce and manufacture food and medical products under safe conditions, and that they apply sound production practices.
   
• These increased activities will offer unique opportunities for engagement with Chinese regulatory counterparts. Direct observation of FDA inspections can bolster Chinese regulators’ understanding of FDA’s requirements and processes and strengthen China’s inspectional capacity.
   
• FDA can also support Chinese regulators’ knowledge of U.S. safety standards through workshops and seminars. These opportunities help facilitate dialogue and encourage scientific exchange on the critical role of inspections in improving the safety and quality of food and medical products.

Risk Analytics for Better Decisions

To best protect Americans, FDA must know as much as possible about emerging public-health trends and risks. By collecting and evaluating information from multiple sources, FDA can identify possible threats and conduct sophisticated risk analyses. The development of a U.S.-based team to analyze assembled data and evaluate risks would also complement assessments and analyses of FDA’s in-country staff.

The proposed budget increase will enable the agency to use informatics tools such as trend analysis, predictive modeling, and geospatial mapping to sharpen FDA’s understanding of possible public-health risks. With the help of risk analytics, FDA can better position itself to address these risks and trends. Better use of data will enable FDA to strengthen its systems in several key areas, including implementation of science-based, harmonized standards. The ultimate goal is to detect and address risks through more preventive, risk-based approaches before they can result in harm to U.S. consumers.

The growing demand by American consumers for Chinese food and medical products requires that FDA develop deeper knowledge and greater expertise in the regulation of these products. Over time, this familiarity will enhance mutual collaboration and enable FDA to increasingly rely on information and actions of its regulatory counterparts. The resulting increase in the safety and quality of Chinese imports will help protect and promote the health of Americans.