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Margaret A. Hamburg

FDA Compliance

China Journal: Strengthening Relationships to Protect Public Health

Highlights from an important trip

Published: Monday, December 8, 2014 - 14:51

I recently wrapped up a jam-packed, five-day visit to China, a fascinating country with a dramatically growing economy and an increasingly significant effect on the products that U.S. citizens consume. Indeed, a key reason for my trip is the important and growing collaboration between the FDA and our counterpart agencies in China for the purpose of ensuring the safety of the large volume of foods and medical products exchanged between our two nations.

Of the 200 countries that export products to the United States, China ranks first in dollar value to our nation. It is the sixth-largest provider of food and also the sixth-largest provider of drugs and biologics. Only the United States has more FDA-registered drug establishments than China. These numbers are growing; between 2007 and 2013, China’s annual exports of FDA-regulated products to the United States nearly quadrupled, reaching 5.2 million “lines” (portions of a shipment) of imported goods in 2013.

Ensuring the safety and quality of these and other U.S.-destined, FDA-regulated goods is a major challenge. To meet it, the FDA has transformed itself from a domestic agency focused primarily on products manufactured in the United States to a truly global agency grappling with the many challenges of globalization.

Among the many efforts in this area, an important component is the FDA’s establishment of permanent outposts, staffed by FDA experts, in all major exporting regions, including China. We have 13 FDA staff members currently stationed in the country, primarily in Beijing. Their job is to help ensure that the food and medical products being exported from China meet our standards. FDA’s China office does this by providing significant support for the agency’s inspections in China, by strengthening our relationships with Chinese regulators, by working with industry and other stakeholders, by providing important information and technical assistance to all interested parties, and by analyzing trends and events that might affect the safety of FDA-regulated products exported from China to the United States.

Given the volume of our trade with China, we are working to more than triple the number of U.S. staff we place in that nation. More FDA experts in China will allow the FDA to significantly increase the number of inspections it performs in this dynamic, strategic country, as well as to be more effective partners with our Chinese colleagues. Such dramatic staffing increases will also allow the FDA to enhance its training efforts and technical collaboration with Chinese regulators, industry, and others.

During my visit, we took an important step forward in strengthening our relationship with China when we signed an implementing arrangement with the Chinese Food and Drug Administration (CFDA). In the coming weeks, we expect to sign a similar implementing arrangement with the General Administration of Quality Supervision, Inspection and Quarantine (AQSIQ). These documents, which build on 2007 agreements with the same two agencies, help to frame the work our inspectors will do in China and create mechanisms for collaboration on inspections.

The FDA is also engaging with other stakeholders to create sustainable models for training future champions of regulatory science and quality. In China, we helped to create a world-class graduate degree program in international pharmaceutical engineering management (IPEM) at Peking University (PKU), an institution renowned for educating Chinese leaders and thinkers.

This partnership with PKU began in 2005 with just two courses on current good manufacturing practices. These proved hugely successful, and drew attention from Chinese drug companies and regulatory agencies, as well as industry and regulators in neighboring countries. The following year, PKU established a master’s degree program in IPEM, with support from the FDA and multinational pharmaceutical companies. The program was formally launched in March 2007, with courses in regulatory science, pharmaceutical science, engineering, and more.

One of the highlights of my trip was speaking to more than 200 PKU students, future leaders who will help to accelerate the modernization of this nation’s pharmaceutical industry. I discussed not only the FDA’s growing regulatory cooperation with China, but also the importance of strengthening regulatory science in China to ensure that the highest standards are used to support the development, review, and approval of new medical products, as well as the manufacturing and safety monitoring of medical products. All of this can make an enormous difference in the lives of patients in China, the United States, and the rest of the world.

Also during my visit, I met with top Chinese regulatory officials, toured CFDA’s mobile laboratories that test for counterfeit drugs and contaminants in food, and attended the Ninth International Summit of Heads of Medicines Regulatory Authorities in Beijing.

Throughout the week, we addressed tough problems that require global solutions. Our discussions ranged from how best to advance biomedical product innovation, expand access to important pharmaceuticals through generic and biosimilar regulatory pathways, and how coordinated action, along with using state-of-the art technologies and analytical methods, will more effectively protect the public from substandard or counterfeit products. We are also making tangible progress in strengthening the FDA’s partnership with our Chinese counterparts to better oversee the increasingly complex international supply chain and to prevent problems before they occur.

All of this bodes well for our ability to promote and protect public health in the future.


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.