FDA’s Latin America Office is responsible for bilateral and multilateral interactions with Mexico and the countries of Central America, South America, and the Caribbean. The objective of this Office is to ensure that the entire range of FDA-regulated products that are developed, tested, manufactured, grown and/or processed from this region and are exported to the U.S. meet FDA requirements. The Latin America Office’s efforts focus primarily on food and animal feed safety protection issues, medical product safety issues, and efforts concerning regulatory oversight of clinical trials, as well as product manufacturing quality. Among the many challenges facing the FDA in the region include the wide geographic diversity and area covered by Latin America, the diversity of product issues and the wide range of sophistication of the regulatory authorities in the region.
The Latin America Office has a physical presence through a regional headquarters in the U.S. Embassy in San Jose, Costa Rica, which opened in 2009, with staff now located in posts in Santiago, Chile (opened in 2009); and in Mexico City, Mexico (which opened in 2010).