FDA to Establish Presence in China

On March 14, 2008, the U.S. Food and Drug Administration (FDA) announced that it had received approval from the State Department to establish offices in China. Subject to final approval by the Chinese government, the outposts will be located at several U.S. diplomatic missions in China, including Beijing, Shanghai and Guangzhou.

The announcement follows a January statement by FDA Commissioner Dr. Andrew von Eschenbach that the FDA was interested in opening satellite offices in U.S. embassies overseas in an attempt to regulate products imported into the U.S. and follows several high-profile recalls involving products made in China, including toothpaste, pet food and the blood thinner heparin.

In December 2007, the U.S. and China concluded two agreements, one covering food and animal feed and another covering drugs and medical devices, which aim to enhance the safety of imported goods into the U.S. market. In addition, both countries have agreed to share greater information regarding manufacturers and suppliers that make goods for the U.S. market.

Additionally, China has agreed to implement quality assurance methods such as electronic tracking which will help regulators trace products and ensure that manufacturers are meeting quality standards throughout the manufacturing process and has agreed to notify U.S. regulators in a wide variety of situations, including when a manufacturing facility has failed an inspection.

Such measures and increasing cooperation between U.S. and Chinese regulators represent a positive step in ensuring the overall quality and safety of imported food and medical products. It will also provide U.S. importers greater flexibility to coordinate inspection efforts with both U.S. and Chinese governmental entities. It should be noted, however, that much of the dynamics of the FDA's presence in China have yet to be finalized and the FDA's presence should not be taken as a substitute for an importer's own quality assurance mechanisms. As such, continued alertness and on-the-ground capabilities of U.S. importers to coordinate quality assurance remain as important as ever. As such, continued alertness and on-the-ground capabilities of U.S. importers are as important as ever, and we recommend importers seek counsel regarding the establishment of their own quality assurance program in China, including an audit of supplier(s).