Medical Translation Insight

Latin America is getting a lot of attention among pharmaceutical companies. Brazil and Mexico are already among the top ten ex-US markets. At the same time, diverse regulatory requirements across these markets create significant obstacles to efficient development and registration of new drugs. Some efforts are being made to harmonize submissions across the continent but complete harmonization is still a ways off.

Because of this lack of harmonization, it can be difficult to obtain information on the local requirements across Latin America. The following three presentations touch on different aspects of the drug submissions process and, together, provide a fairly complete picture:

• A regulatory overview presented by Kendle at the 2008 RAPS conference


• Development of a Harmonized Dossier is a good presentation from the April 2008 CPDG Symposium


• Global Regulatory Strategy looks at various regions around the world, including Latin America (presented at the 2007 DIA Annual Meeting)