Pharmacovigilance is defined by the World Health Organization as the science and practice related to the detection, assessment, understanding and prevention of adverse drug reactions (ADRs). In a well-functioning pharmacovigilance system, information on possible ADRs is collected from patients, health professionals and marketing authorisation holders. Of all data sources for drug safety monitoring, spontaneous reporting systems provide the highest volume of information at the lowest maintenance cost and have proven their value in the early detection of product-related safety issues. At the beginning of 2018, the Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária-Anvisa) decided to replace the national electronic reporting system in Brazil (Notivisa) with the system provided by Uppsala Monitoring Centre (VigiFlow) for ADR reporting. This paper describes that process and reports on the progress made by Anvisa in terms of making Brazil compliant with international pharmacovigilance standards as well as significantly increasing the number of individual case safety reports collected. Key Points Brazilian Health Regulatory Agency (Agência Nacional de Vigilância Sanitária-Anvisa) implemented VigiFlow in 2018 as an initiative to improve the national pharmacovigilance system. Individual case study reports (ICSRs) rates increased after the implementation of Vigiflow in Brazil. From 2020, all pharmacovigilance stakeholders will be able to report ICSRs to VigiFlow, which will expand and reinforce the national use of VigiFlow in the years to come.

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