FDA IN THE INTERNATIONAL ARENA

The Food and Drug Administration (FDA) is a team of dedicated professionals working to protect, promote, and enhance the health of the American people. FDA is responsible for ensuring that:

• foods are safe, wholesome, and sanitary; human and veterinary drugs, biological products, and medical devices are safe and effective; cosmetics are safe; and electronic products that emit radiation are safe;
• regulated products are honestly, accurately, and informatively represented; and
• these products are in compliance with the law and FDA regulations; noncompliance is identified and corrected; and any unsafe or unlawful products are removed from the marketplace.

Products regulated by the agency that are made in other countries must meet the same standards as foods, drugs, cosmetics, and medical devices manufactured domestically. In essence, foods produced in foreign countries for importation to the United States are safe, wholesome, and sanitary; human and veterinary drugs and medical devices and human biological products are safe and effective; cosmetics are safe; electronic products that emit radiation are safe; and all products are properly labeled.

The rapid increase in the development of products and process standards by international and other organizations, and the dramatic rise in imports of FDA-regulated products into the United States have helped to focus the agency's attention on its international role. The agency can better fulfill its mandate to protect and promote the public health by collaborating and cooperating with its foreign regulatory counterparts and international standards-setting organizations to facilitate the compliance by imported products with FDA standards. Given the increase in imports, FDA is continually seeking ways to enhance the efficiency and effectiveness of its international inspection, technical cooperation, and harmonization efforts.

FDA is divided into two functional components: 1) headquarters, located largely in the Washington, D.C. area, where officials direct how the laws mandated by the U. S. Congress and administered by the agency will be enforced, and (2) field offices, located throughout the United States, where operational personnel enforce the law. The field offices, often referred to as "the eyes and ears" of FDA, house the FDA inspectional and laboratory operations. Approximately one-third of FDA's 9,000-plus employees perform field functions.

By imparting a clear explanation of FDA requirements to all nations and firms that import 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 (CGMP), Good Clinical Practice (GCP), Good Laboratory Practice (GLP), 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.

International activities take place in virtually every component of the agency. Most FDA Centers and Offices have established contact points or offices dedicated to enhancing FDA interactions with foreign governments, industry, and international organizations. The Office of International Programs is the focal point for crosscutting international issues for FDA. It is divided into five distinct staffs: Office of the Director; International Agreements Staff, International Relations Staff; International Scientific Activities and Standards Staff; and International Planning and Resources Management Staff. Some points of contact for international issues include:

I. Handling international communications, including emergencies involving FDA-regulated products

• For emergencies or complaints involving FDA-regulated products, contact the Office of Regulatory Affairs/Division of Emergency and Investigational Operations:

• For general questions from foreign government officials and international organizations, contact the International Relations Staff:

• Hosting foreign government officials and visiting scientists. Contact the International Relations Staff's Visitor Coordinator:

• Interacting with the World Health Organization (WHO) and its regional offices to ensure effective collaboration between WHO and FDA. The International Relations Staff is the point of contact:

II. Developing of international agreements (Memoranda of Understanding (MOU), Mutual Recognition Agreements (MRA), etc.) and trade policy that facilitate commerce in FDA-regulated products between the United States and other countries while protecting public health

• The International Agreements Staff is the point of contact for persons outside FDA concerning international agreements and trade issues:

• For information on specific issues related to imported FDA-regulated products, contact the regional import manager or the Division of Import Operation & Policy (DIOP):

III. Serving as experts or members on international harmonization committees to develop internationally accepted standards and requirements for FDA-regulated products

• The International Scientific Activities and Standards Staff serves as a focal point for FDA's international standards and harmonization efforts:

IV. Providing guidance and oversight for technical assistance and engaging in cooperative activities with foreign counterparts in FDA-regulated areas:

• The International Planning and Resource Management Staff (IPRMS) negotiates, coordinates, and provides oversight for technical cooperation by FDA experts with foreign governments and international organizations. FDA program and regulatory staff provide expertise for technical cooperation activities.