List of new cancer drugs and selection of Latin American countries

We constructed a list of cancer drugs approved for new indications by EMA as reported by Davis and col. for the period from 2009 to 2013 [3] and by Naci and col. for the period 2014 to 2016 [10]. We collected for each drug in the list, information about the MA status in LA countries, including the date of the first ever MA issued. Data was collected by one author (CD) and two other authors (MA/MU), working independently with mutual check, during November and December 2019, by scanning the regulator’s web sites of every LA country.

Two explicit exclusion criteria were applied. First, all medicinal products approved initially for an indication other than cancer were excluded. Second, products first approved by EMA before 2009 were also excluded because for approvals before 2009 it was difficult to ascertain the actual first entry dates in LA’s MA databases.

We searched for MA databases in the official regulator’s websites of the 20 continental LA countries (Argentina, Belize, Brazil, Bolivia, Chile, Colombia, Costa Rica, Ecuador, El Salvador, Guatemala, Guyana, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay, Venezuela). Caribbean countries were not included in the search. Only countries having a publicly accessible and trustful MA database were included in the analysis. The minimum requirement was the presence of the active ingredient name and the brand name, presentation, authorization holder and the date of the first MA of the drug in the country.