All Post-approval variations articles
-
EditorialThe region walking the regulatory walk
Latin America (LATAM) is a large market with considerable promise for pharmaceutical growth, with a total potential patient population of more than 600 million people. The landscape in Latin America is changing quickly with demand growing as populations age and chronic diseases become commonplace.
-
JournalRegistration and post-approval variation of pharmaceutical drugs in Latin America:
challenges and opportunitiesThis article provides an overview of the critical challenges for pharmaceutical drug registration and post-approval changes for manufacturers in six major Latin American countries.