Pharmacovigilance Regulatory Requirements in Latin America

  title={Pharmacovigilance Regulatory Requirements in Latin America},
  author={Elise Hoffmann and Alice Fouretier and Caroline Vergne and Delphine Bertram},
  journal={Pharmaceutical Medicine},
Latin American pharmacovigilance systems have developed considerably since the early 1990s and have continued to strengthen. [] Key Result 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.

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The science of collecting, monitoring, researching, assessing and evaluating information from healthcare providers and patients on the adverse effects of medications, biological products, herbalism and traditional medicines with a view to identifying new information about hazards associated with medicines and preventing harm to the patients.


Adherence toward pharmacovigilance activities and system is now based on a paradigm change from care to safety, which scrutinizes the effectiveness of treatment, reduces the adverse consequences to utmost level and guarantees the patient wellbeing.



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