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Table 3 Typology of included literature

From: Governance and pharmacovigilance in Brazil: a scoping review

Literature typology Authorship and date Types of literature Article summary Data extracted
Literature describing ANVISA regulatory reforms and policy instruments ANVISA (2009) ANVISA Stratégias prioritárias da gestão institucional. www.anvisa.gov.br/divulga/noticias/2009/pdf/cartilha_pmg.pdf Agency report ANVISA’s strategies and priorities for institutional management • ANVISA 2008 strategic plan (summary)
• Aims of regulatory management reform
• The Regulatory Agenda as a policy instrument to strengthening regulatory governance through increased transparency and social participation
• ANVISA’s ongoing experience with the regulatory reform
  ANVISA (2009) Gaetani, F., & Albuquerque, K. Capítulo 8: Análise de impacto regulatório e melhoria regulatória Commissioned report: Regulation and Agency Regulators: Governance and analysis of regulatory impact (Chapter 8) Regulatory Impact Analysis (RIA) as a policy instrument to improve regulatory management • Globalization and regulatory reform in Brazil
• Rationale for adoption of global actors’ policy ideas
• Policy, law and regulations adopted for regulatory improvement
• Characterization of RIA as a policy instrument to improve the regulatory decision-making
• ANVISA’s Regulatory Agenda as a policy tool for transparency
• Social participation as a mechanism for transparency
Literature describing ANVISA’s regulatory governance ANVISA (2009) Commissioned report: Regulation and Agency Regulators: Governance and analysis of regulatory impact (Chapter 5) Factors influencing the development of regulatory authorities in Brazil • Characterization of the political and economic conditions influencing regulatory reforms
• Description of enabling legislation for regulatory reform of 10 agencies- including ANVISA
  ANVISA (2009) de Mello, D. R., & Ramalho. Capítulo 11: Boas práticas regulatórias: previsibilidade e transparência na Agência Nacional de Vigilância Sanitária Commissioned report: Regulation and Agency Regulators: Governance and analysis of regulatory impact (Chapter 11) Factors influencing ANVISA’s governance and effectiveness. ANVISA’s best practices for regulatory management to improve accountability and transparency. • Global actors’ influence on ANVISA’s regulatory governance
• ANVISA’s characteristics and scope
• Relationship between ANVISA’s governance, accountability and transparency
Literature describing global actors’ influence and norms in Brazil pertaining to governance or pharmacovigilance ANVISA (2009) Cruz, V. Capítulo 2: Estado e regulação: fundamentos teóricos Commissioned report: Regulation and Agency Regulators: Governance and analysis of regulatory impact (Chapter 2) Factors influencing the development of regulatory authorities in Brazil • Global actors’ influence on regulatory reform and ANVISA’s governance structure
• Rationale for adoption of global actors’ policy ideas
  Dainesi, S. (2005). Journal Article Implementation of pharmacovigilance in Brazil • Characterization of pharmacovigilance pertaining to efficiency and transparency
• Recommendations for supporting a culture of disclosure to advance pharmacovigilance
  PAHO. (2011) Commissioned report: Description of PAHO best practices for pharmacovigilance • PAHO norms for pharmacovigilance
Literature describing ANVISA and the pharmacogovernance domain(s) Biehl, J., et al. (2009). Princeton University, Princeton Commentary Description of the growing trend of litigation to gain access to medicines in the context of incomplete knowledge of the safety of medicines. • Need for transparency in drug approval process and placement of drugs on SUS formulary.
  Cruz, V. (2010) Journal Article ANVISA is used as a case study of institutionalized mechanisms for accountability and transparency • Civil society participation as a mechanism to increase regulatory accountability and transparency
• Global actors’ influence on ANVISA’s regulatory governance
• ANVISA’s management contract as an instrument of accountability
  Freitas, M. & Romano-Lieber, N. (2007) Journal Article Laws pertaining to pharmacovigilance and industry • Laws requiring ADR reporting by industry
• Laws requiring industry pharmacovigilance departments
• Evaluation of the effectiveness of laws
  Gava, C., et al. (2010) Journal Article Medicines registration process for new and generic drugs • Characterization of Brazil’s drug registration process
• Description of processes lacking transparency
  Miranda, A. (2010). Dissertation ANVISA’s experience with transparency in regulatory management • Characterization of the conditions leading to drug safety reforms
• Characterization of ANVISA’s scope and mandate
• Social participation and transparency in regulatory management
• Characterization of the effectiveness of ANVISA’s actions to include social participation in decision making
  Mastroianni PC, Lucchetta RC. (2011) Journal article ANVISA and the drug approval process • ANVISA’s role in protecting medicines safety
• Drug registration and re-registration requirements
  Pereira, M. F. (2010) Thesis Social participation and community health councils • Characterization of social participation as a mechanism of governance in Brazil
  Prat, A. G. (2013) Journal Article Laws pertaining to drug approval • ANVISA requirements for drug registration in Brazil
  Silva, G. H. (2011). IV Congresso CONSAD de Gestao Publica. Conference paper ANVISA’s experience using the Regulatory Impact Analysis • Global actors’ influence on ANVISA’s regulatory reforms with emphasis on transparency and accountability
• Characterization of ANVISA’s Regulatory Process Improvement Programme including the Regulatory Agenda
• Analysis of the implementation of the Regulatory Agenda
• Characterization of effectiveness and remaining gaps
  Vashisth, S., Singh, G., & Nanda, A. (2012) Journal Article Comparative study of pharmacovigilance in Brazil, Russia, India and China • Requirements for drug approval
• Characterization of effectiveness and gaps in pharmacovigilance
• Recommendations to strengthen pharmacovigilance (e.g., enforcement)