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Overview of the
Office of International Programs

The agency focal point for international issues that cut across product lines is FDA's Office of International Programs.

U.S. imports reached over 6 million shipments, worth $80 billion, in 2000, and they are rising sharply. FDA lacks the resources to inspect a meaningful proportion of these products when they arrive at the more than 150 U.S. ports of entry. (Although FDA inspectors review 100 percent of entry documents, they physically inspect less than one percent of all imports.) The agency therefore uses several approaches to ensure that imports meet the high U.S. public health standards before they leave the exporting country:

• Memoranda of Understanding (MOUs). FDA has negotiated more than 50 MOUs that commit the governments of the exporting countries to make sure that their products destined for the United States meet U.S. standards.
• Inspections. FDA's specialists inspect foreign facilities that export food, medications and other critical regulated products to the U.S. to make certain that they follow good manufacturing practices. Approximately 1000 of these inspections are done each year.
• Training. FDA trains its regulatory counterparts in the exporting countries in U.S. public health requirements and in methods to assure that exporters meet these requirements.
• Higher international standards. FDA is making significant contributions to the efforts of organizations such as Codex Alimentarius and the International Organization for Standards, to raise the standards for food, medical devices and other regulated products worldwide.
• Harmonization of guidelines. FDA has taken the lead in founding international organizations that combine the efforts of regulatory authorities and industry associations to harmonize regulatory guidelines for new drugs (International Conference on Harmonisation), medical devices (Global Harmonization Task Force) and veterinary medications (Veterinary International Conference on Harmonisation).
• Mutual Recognition Agreements. For example, FDA is implementing an agreement under which it could rely on its counterparts in the European Union to inspect European plants that export regulated products (pharmaceuticals and medical devices) to the United States, and vice versa.

In addition to protecting American consumers, FDA oversight contributes significantly to the worldwide acceptance of foods, pharmaceuticals, medical devices and other FDA-regulated products.

By imparting a clear explanation of FDA requirements to all nations and firms that export FDA-regulated products to the United States, the agency is able to assist in facilitating exports of products that meet its requirements and discouraging those that are violative. Therefore, FDA assists foreign (and domestic) manufacturers in understanding how to comply with FDA's Current Good Manufacturing Practice, Good Clinical Practice, Good Laboratory Practice, Procedures for the Safe and Sanitary Processing and Importing of Fish and Fishery Products, known as Hazard Analysis and Critical Control Point (HACCP), and other regulations.

As a global leader and the world's premier consumer protection regulatory agency, a strong FDA is essential to continued protection of the health of American consumers, and to improving public health worldwide.

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