Leading Article

Pharmaceutical Medicine

, Volume 26, Issue 3, pp 153-164

First online:

Pharmacovigilance Regulatory Requirements in Latin America

  • Elise HoffmannAffiliated withClinical Research Department, Hospices Civils de Lyon Email author 
  • , Alice FouretierAffiliated withClinical Research Department, Hospices Civils de Lyon
  • , Caroline VergneAffiliated withClinical Research Department, Hospices Civils de Lyon
  • , Delphine BertramAffiliated withClinical Research Department, Hospices Civils de Lyon

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Latin American pharmacovigilance systems have developed considerably since the early 1990s and have continued to strengthen. The aim of this article is to review and analyse pharmacovigilance regulatory requirements governing the pharmaceutical industry’s activities in 21 countries in Latin America (Argentina, Bolivia, Brazil, Chile, Colombia, Costa Rica, Cuba, Dominican Republic, Ecuador, El Salvador, Guatemala, Haiti, Honduras, Mexico, Nicaragua, Panama, Paraguay, Peru, Suriname, Uruguay and Venezuela). For marketed pharmaceutical products, 16 countries have set up modalities of immediate reporting of adverse events (such as type of adverse event, report format, timelines and receivers) and only nine of them have implemented modalities for the periodic reporting of adverse events. Six countries have also established specific requirements for adverse events related to vaccines. Regarding clinical trials, ten countries have regulations for the immediate reporting of adverse events, and eight of them for periodic reporting.

When a country’s regulatory requirement level is compared with its Human Development Index (HDI), which integrates three basic dimensions of human development (i.e. health, education and standard of living), it appears that there is a correlation (2011 values): the mean of the HDI is 0.749 for high-level countries, 0.729 for medium-level countries and 0.604 for low-level countries. Most Latin American countries have high or medium levels of regulatory pharmacovigilance requirements, in line with international standards. Countries that have a low requirement level must still develop a pharmacovigilance system and appropriate regulatory measures, and they are strongly encouraged and supported by the WHO. The Subregional Pharmacovigilance Programmme and the Pan American Network for Drug Regulatory Harmonization also help the countries in Latin America to develop and harmonize pharmacovigilance regulations.