Strategic objectives of Health Regulatory Agencies: an international comparative study

Detalhes bibliográficos
Autor(a) principal: Brito, Rodrigo Lino de
Data de Publicação: 2019
Outros Autores: Flexa, Raquel Gonçalves Coimbra
Tipo de documento: Artigo
Idioma: por
eng
Título da fonte: Vigilância Sanitária em Debate
Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271
Resumo: Introduction: This article presents a comparative panorama between the current strategic maps of three of the world’s major regulatory agencies, in order to allow the analysis of the future objectives of these entities, as well as to understand the alignments and particularities of each organization. Objective: To analyze and compare the strategic maps of the National Health Regulatory Agency in Brazil (Anvisa); the US Food and Drug Administration (FDA) in the United States; and the European Medicines Agency (EMA) in the European Union. Method: This is a qualitative research which used the content analysis method and the technique of meaning condensation to structure and interpret findings. Results: It can be seen that all the analyzed entities have, in the organization of their management, the definition of planning processes, with the design of strategic objectives in synthetic maps and focused on problems, declaring their strategy with clarity, conciseness and objectivity. In addition, the degree of homogeneity of issues, as well as a text that is coherent with the state of the art of the regulatory field, favor the alignment between such agencies, making possible a greater international regulatory convergence. Conclusions: Explaining the strategy in the right way helps to provide organizational management with systemic analysis, focus, direction and intentionality,which certainly influences the achievement of the expected results.
id FIOCRUZ-9_ac6ab56edc268abc0c76e8d6730eb367
oai_identifier_str oai:ojs.visaemdebate.incqs.fiocruz.br:article/1271
network_acronym_str FIOCRUZ-9
network_name_str Vigilância Sanitária em Debate
repository_id_str
spelling Strategic objectives of Health Regulatory Agencies: an international comparative studyObjetivos estratégicos de Agências Reguladoras em Saúde: um estudo comparativo internacionalStrategic PlanningStrategic ObjectivesHealth RegulationRegulatory AgenciesPlanejamento EstratégicoObjetivos EstratégicosRegulação SanitáriaAgências ReguladorasIntroduction: This article presents a comparative panorama between the current strategic maps of three of the world’s major regulatory agencies, in order to allow the analysis of the future objectives of these entities, as well as to understand the alignments and particularities of each organization. Objective: To analyze and compare the strategic maps of the National Health Regulatory Agency in Brazil (Anvisa); the US Food and Drug Administration (FDA) in the United States; and the European Medicines Agency (EMA) in the European Union. Method: This is a qualitative research which used the content analysis method and the technique of meaning condensation to structure and interpret findings. Results: It can be seen that all the analyzed entities have, in the organization of their management, the definition of planning processes, with the design of strategic objectives in synthetic maps and focused on problems, declaring their strategy with clarity, conciseness and objectivity. In addition, the degree of homogeneity of issues, as well as a text that is coherent with the state of the art of the regulatory field, favor the alignment between such agencies, making possible a greater international regulatory convergence. Conclusions: Explaining the strategy in the right way helps to provide organizational management with systemic analysis, focus, direction and intentionality,which certainly influences the achievement of the expected results.Introdução: Esse artigo apresenta um panorama comparativo entre os mapas estratégicos atualmente vigentes de três das grandes agências reguladoras de peso mundial, de modo a possibilitar a análise dos objetivos de futuro desses entes, assim como entender alinhamentos e particularidades de cada organização. Objetivo: Analisar e comparar os mapas estratégicos da Agência Nacional de Vigilância Sanitária (Anvisa), no Brasil; do US Food and Drug Administration (FDA), nos Estados Unidos; e da European Medicines Agency (EMA), da União Europeia. Método: Trata-se de uma pesquisa qualitativa, que utilizou o método de análise de conteúdo e a técnica de condensação de significados para estruturar e interpretar os achados. Resultados: Percebe-se que todas as entidades analisadas têm, na organização de sua gestão, a definição de processos de planejamento, com o desenho de objetivos estratégicos em mapas sintéticos e focados em problemas, declarando a estratégia com clareza, concisão e objetividade. Além disso, o grau de  homogeneidade de temas, assim como a redação coerente com o estado da arte do campo regulatório favorecem o alinhamento entre tais agências, possibilitando maior convergência regulatória internacional. Conclusões: Explicitar a estratégia da maneira correta ajuda a dotar a gestão organizacional de análise sistêmica, foco, direção e intencionalidade, o que certamente influi no atingimento dos resultados esperados.Instituto Nacional de Controle de Qualidade em Saúde2019-08-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/127110.22239/2317-269X.01271Health Surveillance under Debate: Society, Science & Technology ; Vol. 7 No. 3 (2019): August; 3-13Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 3 (2019): Agosto; 3-13Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 3 (2019): Agosto; 3-132317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271/1032https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271/1117Copyright (c) 2019 Vigilância Sanitária em Debate: Sociedade, Ciência & Tecnologia (Health Surveillance under Debate: Society, Science & Technology) – Visa em Debatehttps://creativecommons.org/licenses/by-nc-nd/4.0info:eu-repo/semantics/openAccessBrito, Rodrigo Lino deFlexa, Raquel Gonçalves Coimbra2023-06-27T15:11:24Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1271Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:11:24Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Strategic objectives of Health Regulatory Agencies: an international comparative study
Objetivos estratégicos de Agências Reguladoras em Saúde: um estudo comparativo internacional
title Strategic objectives of Health Regulatory Agencies: an international comparative study
spellingShingle Strategic objectives of Health Regulatory Agencies: an international comparative study
Brito, Rodrigo Lino de
Strategic Planning
Strategic Objectives
Health Regulation
Regulatory Agencies
Planejamento Estratégico
Objetivos Estratégicos
Regulação Sanitária
Agências Reguladoras
title_short Strategic objectives of Health Regulatory Agencies: an international comparative study
title_full Strategic objectives of Health Regulatory Agencies: an international comparative study
title_fullStr Strategic objectives of Health Regulatory Agencies: an international comparative study
title_full_unstemmed Strategic objectives of Health Regulatory Agencies: an international comparative study
title_sort Strategic objectives of Health Regulatory Agencies: an international comparative study
author Brito, Rodrigo Lino de
author_facet Brito, Rodrigo Lino de
Flexa, Raquel Gonçalves Coimbra
author_role author
author2 Flexa, Raquel Gonçalves Coimbra
author2_role author
dc.contributor.author.fl_str_mv Brito, Rodrigo Lino de
Flexa, Raquel Gonçalves Coimbra
dc.subject.por.fl_str_mv Strategic Planning
Strategic Objectives
Health Regulation
Regulatory Agencies
Planejamento Estratégico
Objetivos Estratégicos
Regulação Sanitária
Agências Reguladoras
topic Strategic Planning
Strategic Objectives
Health Regulation
Regulatory Agencies
Planejamento Estratégico
Objetivos Estratégicos
Regulação Sanitária
Agências Reguladoras
description Introduction: This article presents a comparative panorama between the current strategic maps of three of the world’s major regulatory agencies, in order to allow the analysis of the future objectives of these entities, as well as to understand the alignments and particularities of each organization. Objective: To analyze and compare the strategic maps of the National Health Regulatory Agency in Brazil (Anvisa); the US Food and Drug Administration (FDA) in the United States; and the European Medicines Agency (EMA) in the European Union. Method: This is a qualitative research which used the content analysis method and the technique of meaning condensation to structure and interpret findings. Results: It can be seen that all the analyzed entities have, in the organization of their management, the definition of planning processes, with the design of strategic objectives in synthetic maps and focused on problems, declaring their strategy with clarity, conciseness and objectivity. In addition, the degree of homogeneity of issues, as well as a text that is coherent with the state of the art of the regulatory field, favor the alignment between such agencies, making possible a greater international regulatory convergence. Conclusions: Explaining the strategy in the right way helps to provide organizational management with systemic analysis, focus, direction and intentionality,which certainly influences the achievement of the expected results.
publishDate 2019
dc.date.none.fl_str_mv 2019-08-27
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
"Peer-reviewed article"
"Artículo revisado por pares"
"Artigo avaliado pelos pares"
format article
status_str publishedVersion
dc.identifier.uri.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271
10.22239/2317-269X.01271
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271
identifier_str_mv 10.22239/2317-269X.01271
dc.language.iso.fl_str_mv por
eng
language por
eng
dc.relation.none.fl_str_mv https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271/1032
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1271/1117
dc.rights.driver.fl_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
info:eu-repo/semantics/openAccess
rights_invalid_str_mv https://creativecommons.org/licenses/by-nc-nd/4.0
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
publisher.none.fl_str_mv Instituto Nacional de Controle de Qualidade em Saúde
dc.source.none.fl_str_mv Health Surveillance under Debate: Society, Science & Technology ; Vol. 7 No. 3 (2019): August; 3-13
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 7 Núm. 3 (2019): Agosto; 3-13
Vigil Sanit Debate, Rio de Janeiro; v. 7 n. 3 (2019): Agosto; 3-13
2317-269X
reponame:Vigilância Sanitária em Debate
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Vigilância Sanitária em Debate
collection Vigilância Sanitária em Debate
repository.name.fl_str_mv Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv incqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br
_version_ 1797042045348478976