FDA Opens Office in Mexico City

The Food & Drug Administration grows its international presence with a new office in Mexico's capital city
¡Viva la regulation!

Ref: Posted by The FDA on February , 2010.

The Food & Drug Administration has open an office in Mexico City, as it looks to expand its presence outside of the U.S.

The federal agency's latest outpost is its third in Latin America and 10th international post in the past 13 months. Staff members at the Mexico City post will work with their Mexican counterparts to "harmonize regulations and guidance standards and to work on other collaborative initiatives" by sharing information about each country's respective regulatory requirements for both medical & pharmaceutical products and Clinical Trials Regulatory Oversight. 

Given the wide geographic diversity and area covered by Latin America, given the diversity of product issues, and given the diversity of sophistication of the regulatory authorities in the region, a presence in only one country would not suffice to cover FDA needs in the region. FDA therefore plans to establish a presence in San Jose, Costa Rica and Mexico City, Mexico, and perhaps another location to be determined.

The Latin America FDA office will focus efforts primarily on food and feed safety and protection issues and will focus medical product safety issues on supporting more in depth the efforts concerning "clinical trials regulatory oversight" and regulatory oversight of product manufacturing quality.

The Food and Drug Administration is going global. The agency announced on January/2010 it has open an office in Mexico City - the FDA's 10th new international office in the last 13 months.

"More than a third of Medical Devices come from Mexico  said FDA Commissioner  in a statement. "Having FDA experts located permanently there will be mutually beneficial to both our countries and respective citizens."

In Mexico, FDA staff will work with their counterparts in the Mexican government to harmonize regulations and guidance standards. Other initiatives include information-sharing on respective regulatory systems and joint workshops on the safety of  pharmaceutical and medical products. Both governments will also look for opportunities for joint training  “FDA experts in Mexico City will work closely with local industries that ship pharmaceutical and medical products to the United States to improve their understanding of U.S. safety and product quality expectations,” said deputy commissioner for International Programs at the FDA. “Their activities will include providing technical advice and working with government agencies and the private sector to develop certification programs.”

The FDA’s nine other overseas offices are in China, India, Europe, and Latin America.