Regulatory Affairs in Latin America
On the 20th and 21st of February of 2014, representatives of the five Latin-American Health Authorities of Regional Reference recognized by the Pan American Health Organization, plus those of the FDA, Health Canada, and El Salvador’s regulatory agency met in Acapulco, Mexico, for a Summit of Health Authorities.
The topics of the agenda were regulation harmonization, reduction of transaction costs, and facilitation of access to drug products and vaccines of high quality and low cost.
Representatives of the American Health Authorities. Photo: COFEPRIS website.
The Health Authorities certified as of Regional Reference currently are those of Mexico (COFEPRIS), Argentina (ANMAT), Colombia (INVIMA), Brazil (ANVISA) and Cuba (CECMED). During the meeting, the representatives of FDA and Health Canada announced their decision to seek the PAHO certification for their own institutions.
The recognition will follow an evaluation of the agencies’ performance of basic functions, recommended by WHO, for ensuring the quality, safety…
View original post 177 more words