Very few industries, if any, have endured higher government regulation than pharmaceuticals. In Latin America, the regulatory scenario is one of permanent change. The most profound changes began 20 years ago in Mexico, Brazil and Argentina, shortly followed by Chile and Colombia, and today they are radiating out across the continent. Brazil’s new board seat on the ICH (International Council for Harmonisation of technical requirements for pharmaceuticals for human use) has accelerated these changes, pulling the whole of Latin America into line. It is not an exaggeration to state that, today, in the countries mentioned, the regulatory requirement for pharmaceutical products resembles that of Europe. As a leading pharmaceutical organisation with a specialisation in prescription drugs, and with operations in more than 18 Latin American countries, Megalabs has seen and experienced these changes first hand over the past two decades. Within that timeframe, the Latin American population gr