ArticleJournal of pharmaceutical policy and practice2016
Governance and pharmacovigilance in Brazil: a scoping review.
Article in Journal of pharmaceutical policy and practice, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
What it found
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Who cites it
11 citing papers in PubMed.
- From Traditional Knowledge to SARS-CoV-2 Entry Inhibitor Metabolites: Ethnopharmacological Investigation ofPlants (Basel, Switzerland) · 2026Article
- Artificial Intelligence in Telemedicine: philosophical, ethical, and epistemological dimensions of a transforming practice.Einstein (Sao Paulo, Brazil) · 2026Review
- Article
- The Art of Bioimmunogenomics (BIGs) 5.0 in CAR-T Cell Therapy for Lymphoma Management.Advanced pharmaceutical bulletin · 2024Review
- Cross-sectional study of pharmacovigilance knowledge, attitudes, and practices based on structural equation modeling and network analysis: a case study of healthcare personnel and the public in Yunnan Province.Frontiers in public health · 2024Article
- Drug utilization research in Peru: Is real-world data available?Frontiers in pharmacology · 2022Article
- Article
- Challenges to the consolidation of pharmacovigilance practices in Brazil: limitations of the hospital pharmacist.Therapeutic advances in drug safety · 2020Article
- Transnational pharmacogovernance: emergent patterns in the jazz of pharmaceutical policy convergence.Globalization and health · 2018Article
- Matching safety to access: global actors and pharmacogovernance in Kenya- a case study.Globalization and health · 2017Article
- Comparative evaluation of pharmacovigilance regulation of the United States, United Kingdom, Canada, India and the need for global harmonized practices.Perspectives in clinical researchReview
Corrections and comments
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Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundThis scoping review investigates the relationship between governance, pharmacovigilance, and Agencia Nacional de Vigilancia Sanitaria (ANVISA) in Brazil, which has authority over Brazil's national pharmaceutical policy, drug registration and coordination of the national pharmacovigilance system. The purpose is to investigate opportunities for effective pharmacovigilance.
methodsSixty-three terms pertaining to pharmacovigilance in Brazil and ANVISA, global institutions, pharmaceutical industry, and civil society were searched in thirteen relevant databases on November 17-18, 2013. Using a pharmacogovernance framework we analyzed ANVISA's pharmacogovernance: the manner in which governing structures, policy instruments, and institutional authority are managed to promote societal interests for patient safety due to medication use. The integration of transnational policy ideas for regulatory governance into pharmacogovernance in Brazil was also investigated.
resultsBrazil's policy, laws, and regulations support ANVISA's authority to ensure access to safe medicines and health products however ANVISA's broad mandate and gaps in pharmacogovernance account for regional disparities in monitoring and assessing drug safety. Gaps in pharmacogovernance include: equity and inclusiveness; stakeholder coordination; effectiveness and efficiency; responsiveness; and intelligence and information.
conclusionsPharmacogovernance that addresses 1) regional resource disparities, 2) federal and state lack of coordination of pharmacovigilance regulations, 3) asymmetric representation in the pharmaceutical regulatory agenda and which 4) disaggregates regulatory authority over health and commercial sectors would strengthen pharmacovigilance in Brazil.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.