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The National Pharmacovigilance System (NPS), as part of the Brazilian Public Health System, has been updated in the last few years to address the challenges related to structural characteristics and limited resources. The purpose of this chapter is to present the NPS and bring focus to partnerships with international organizations, which have contributed to advances in pharmacovigilance, especially the Uppsala Monitoring Centre (UMC). As a result of this approach, the Brazilian pharmacovigilance system has improved. The Brazilian reporting electronic system has been replaced by UMC’s system (VigiFlow); the national pharmacovigilance regulatory framework for Marketing Authorization Holders (MAH) has been updated. Consequently, the number of Individual Case Safety Reports (ICSR) received by ANVISA increased by 62.6% in 2019.

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The State of Pharmacovigilance in Brazil

  • 章节

  • 发表日期：

    2025年

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  • Marcelo Vogler de Moraes,
  • Yannie Silveira Gonçalves

摘要

The National Pharmacovigilance System (NPS), as part of the Brazilian Public Health System, has been updated in the last few years to address the challenges related to structural characteristics and limited resources. The purpose of this chapter is to present the NPS and bring focus to partnerships with international organizations, which have contributed to advances in pharmacovigilance, especially the Uppsala Monitoring Centre (UMC). As a result of this approach, the Brazilian pharmacovigilance system has improved. The Brazilian reporting electronic system has been replaced by UMC’s system (VigiFlow); the national pharmacovigilance regulatory framework for Marketing Authorization Holders (MAH) has been updated. Consequently, the number of Individual Case Safety Reports (ICSR) received by ANVISA increased by 62.6% in 2019.