Background: This scoping review investigates the relationship between governance, pharmacovigilance, and Agencia\nNacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug\nregistration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for\neffective pharmacovigilance.\nMethods: Sixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical\nindustry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a\npharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing\nstructures, policy instruments, and institutional authority are managed to promote societal interests for patient\nsafety due to medication use. The integration of transnational policy ideas for regulatory governance into\npharmacogovernance in Brazil was also investigated.\nResults: Brazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health\nproducts however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in\nmonitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder\ncoordination; effectiveness and efficiency; responsiveness; and intelligence and information.\nConclusions: Pharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of\ncoordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory\nagenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen\npharmacovigilance in Brazil.
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