The US Food and Drugs Administration, Latin America Regional Office

The Food and Drug Administration (FDA), Latin America Office is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supply, cosmetics, and products that emit radiation made available to the American public.

The establishment of an FDA Regional Office in Latin America is part of a larger Agency initiative that covers the globe including establishing offices in China, India, and Europe. Our Latin America regional headquarters is located in Costa Rica. We also have offices in Mexico City, Mexico and Santiago, Chile. The regional office covers Mexico, Central America, South America, and the Caribbean.

Mission Statement:

FDA Latin America Office serves as the focal point within the Latin America region to manage, and coordinate FDA’s international activities with the following goals:

• Serve as a portal to facilitate information exchange, to provide easier access to regulations, guidance documents and to individuals who can answer questions about them.
• Work closely with regulatory authorities, industry and academia on projects geared towards reaching the goal of safe food and effective and high quality medical products.
• Identify ways to exchange information and leverage resources with our foreign counterparts, as well as identifying conditions within the region that have a direct impact on FDA regulated products that are exported to the U.S.
• Engage with counterpart regulatory authorities and industry to ensure the timely exchange of information regarding the manufacturing, processing, quality and safety of FDA-regulated products exported from the region.
• Collaborate with regulated industries in the region that wish to export their products to the U.S. to ensure their understanding of our standards, and expectations regarding FDA-regulated products.
• Obtain better and more robust information to help officials in the various FDA headquarter Offices, Centers and at the borders make better decisions about the products from Latin America that are being developed for the U.S. market.
• Develop close relationships with regulatory counterparts and/or partnering with counterpart agencies to leverage resources for various bilateral and regional capacity building initiatives.
• Conduct regulatory inspections in coordination with the local competent authorities.