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. CapÃtulo 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. CapÃtulo 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. CapÃtulo 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) |