FDA Works with China to Ensure Medical-Product Safety

By: Christopher Hickey, Ph.D.

Americans benefit greatly from medical products produced by other countries. Approximately 40 percent of finished drugs in the United States come from overseas, as well as more than 50 percent of all medical devices. About 80 percent of the manufacturers of active pharmaceutical ingredients are located outside the United States.

Christopher Hickey

Christopher Hickey, Ph.D., testifies April 3, 2014.

However, this rapid globalization of commerce presents challenges to regulators who oversee the safety and quality of medical products. Many of these challenges manifest themselves in China. As FDA’s country director for the People’s Republic of China, I testified on April 3, 2014 before the U.S.-China Economic and Security Review Commission, an advisory panel created by Congress, on our work to ensure the safety and quality of medical products produced in China and imported into the United States.

China is the source of a large and growing volume of imported foods, medical products and ingredients. In the years spanning fiscal years 2007 and 2013, the total number of shipments of FDA-regulated products from China to the United States almost quadrupled.

The challenges we see in China mirror those we see in other countries with developing regulatory systems. These issues include problems with data integrity, inadequate implementation of quality systems in manufacturing, and inconsistent regulatory oversight, among others.

As China’s role on the global stage expands, FDA has significantly increased drug and medical device inspections there, but we need to continue to strengthen our efforts. FDA is currently working to use Congressionally-appropriated funding to increase from eight to 27 the number of U.S. staff it posts in China. Visa issues that arose with the Chinese government over new FDA staff assigned there were addressed during Vice President Joe Biden’s visit to Beijing in December, and FDA continues its work to post new staff in Beijing in the coming months.

FDA recognizes that strategic engagement in China starts first and foremost with Chinese regulators. China’s Food and Drug Administration, or CFDA, is responsible for the regulation of food, drugs, and devices for domestic distribution in China, and for regulation of certain exported drugs and medical devices.

Senate Committee Hearing, April 3, 2014

Christopher Hickey, Ph.D., testifies before the U.S.-China Economic and Security Review Commission.

FDA has established a strong working relationship with CFDA. Our office has trained hundreds of Chinese inspectors in areas that include inspecting for good manufacturing practices and assessing the quality of data from sites that conduct clinical trials. Experts from FDA’s Center for Devices and Radiological Health now meet regularly with their counterparts from CFDA under the auspices of the International Medical Devices Regulatory Forum. These investments will pay long-term dividends for the American people: a stronger Chinese regulatory system can only strengthen FDA’s efforts to promote and protect U.S. public health.

Finally, in the area of inspections and enforcement, CFDA inspectors now regularly observe FDA inspections in China. And since 2012, FDA’s Office of Criminal Investigations has worked closely with CFDA to fight against Internet-based, illegal distribution into the U.S. of falsified, counterfeit and adulterated drugs.

FDA’s priorities in China match its global priorities: we work to ensure the safety and efficacy of FDA-regulated products. Manufacturers are best situated to make certain that appropriate processes are in place to ensure safety and quality in production. Regulatory bodies should hold companies accountable for lapses in the production process. Inspections and testing are important tools in that process, but they must be used as part of a larger system that emphasizes a preventive, approach to the production of safe, effective, high-quality medical products.

And in our globalized world, it’s increasingly important that regulatory partners work together to ensure the safety of products as they move through increasingly complex supply chains. Patients and consumers – whether in Beijing or Boston – deserve no less.

Christopher Hickey, Ph.D., is FDA’s Country Director for the People’s Republic of China.

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China’s Healthcare Sector, Drug Safety, and the U.S.-China Trade in Medical Products

China Takes Steps to Strengthen Food Safety

By: Camille Brewer, M.S., R.D.

An important message came through loud and clear during FDA’s whirlwind visit to China this month: China is determined to strengthen its food safety system. I had not visited China in nearly 10 years and I was struck by the extraordinary progress in the cities we visited. The towering skyscrapers, tree-lined boulevards, and the obvious signs of a rising middle class demonstrate the reality of an economy that has grown by leaps and bounds. That growth has led to rising consumer expectations, and China is clearly working hard to meet consumer and global expectations for safe food. 

This message was repeated in meeting after meeting that Mike Taylor, Deputy Commissioner for Foods and Veterinary Medicine, and I had with Chinese officials. We saw a clear recognition of the scope and complexity of the challenge as well as a resolve—indeed, an enthusiasm—to take on the challenges head-on, and develop a modern, effective, and efficient food safety system.

Make no mistake: this will not be easy for China.  It has considerable catching up to do in the science and daily practice of food safety and in its legal system.  But the enthusiasm and commitment we saw seems real, and is backed up by action.

China is now implementing its first comprehensive food safety law, which established a Food Safety Committee to oversee all ministries responsible for food safety. The law also calls for the establishment of a national center to focus on risk assessment and risk monitoring to strengthen the scientific underpinnings of food safety regulations.

Earlier this year, China issued a five-year plan for national food safety supervision.  The plan directs the Food Safety Committee and its working office to oversee improvements intended to strengthen China’s food safety regulatory system, emergency response capabilities, supply chain management, surveillance systems, standard-setting activities, and third-party testing. It also calls for improved risk communication and interagency coordination among regulators at central, provincial, and local levels. This plan is testimony to the resolve of the Chinese government to elevate the importance of food safety.

FDA has been working very closely with China for some time to enhance cooperation and address food safety issues of concern. Today, FDA and Chinese food safety authorities renewed an agreement originally signed in 2007. Under the agreement, FDA has helped China to strengthen its regulatory system and better understand FDA’s food safety requirements. This cooperation was made much easier when FDA established offices in China in 2008, enabling us to dramatically increase our inspections and conduct workshops for Chinese government and industry representatives.

On our trip, we also noticed increased consumer interest in food safety. We met with a professor and blogger from China Agricultural University who emphasized Chinese consumers’ concern about economic fraud.  A representative from the Shanghai State FDA and Shanghai Food Safety Committee told us that they have established a consolidated consumer hotline for food safety concerns. 

Michael R. Taylor, Deputy Commissioner for Foods and Veterinary Medicine

This consumer focus dovetailed well with the presentation made by Mike Taylor at the China International Food Safety and Quality Conference in Shanghai. He noted that consumer confidence in the food supply is an important goal, and what is needed to improve food safety is also what is needed to strengthen consumer confidence in the food they eat. That’s an industry commitment to food safety, credible and effective government oversight, public-private collaboration and partnership, and transparency on the part of industry and government.

He noted that countries other than China are pursuing similar food safety initiatives. In addition to the United States, which is implementing the FDA Food Safety Modernization Act, the Canadian Senate recently passed the Safe Food for Canadians Act, and the Dominican Republic, Madagascar and Vietnam are among countries pursuing modernized food safety laws.

During our trip, we also met with representatives of multinational corporations doing business in China and visited a canned food facility in operation in the Huairou District, a suburb of Beijing.

We know there is still a lot of work ahead to improve food safety worldwide, and efforts by our trading partners must be combined with strong oversight by U.S.government agencies. The FDA Food Safety Modernization Act gives us new tools to improve that oversight, so the elements that are necessary to improve both food safety and consumer confidence are coming together.

The speech presented by Mike Taylor can be accessed at the following link: http://www.fda.gov/Food/FoodSafety/FSMA/ucm326870.htm.

The text of the 2007 agreement, which was officially renewed on December 11, 2012, is available at: http://www.fda.gov/InternationalPrograms/Agreements/MemorandaofUnderstanding/ucm107557.htm

Camille Brewer is Director of International Affairs at FDA’s Office of Foods and Veterinary Medicine