Recently, the Chinese government granted diplomatic approval to the U.S. Food and Drug Administration (FDA) to open three offices in China. The process of establishing the FDA's China presence began in December 2007, when the U.S. and China concluded two agreements. One agreement covered food and animal feed, and the other covered drugs and medical devices. Both were aimed at enhancing the safety of imported goods into the U.S. market. Both countries have also agreed to share greater information regarding manufacturers and suppliers that make goods for the U.S. market.
In addition, 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.
These developments stem from well-publicized product and regulatory events recently. These events have increased the focus of FDA and the public on products and components of products manufactured in places such as China and India. This announcement reinforces the need of U.S. companies to have in place robust quality and regulatory systems that include products and components of products sourced from outside the U.S. Agreements between U.S. companies and foreign suppliers should explicitly address these needs, systems to maximize quality and regulatory compliance, as well as the allocation of responsibility and oversight for such activities.
China's approval of the FDA offices and increasing cooperation between U.S. and Chinese regulators represent a positive step in improving the overall quality and safety of imported food and medical products. It will also provide U.S. manufacturers and 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 a manufacturer's or importer's own quality and compliance systems. As such, continued alertness and on-the-ground capabilities of U.S. companies to coordinate quality and regulatory compliance remain critical.