Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023
Autor(a) principal: | |
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Data de Publicação: | 2023 |
Outros Autores: | , |
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/2161 |
Resumo: | Introduction: The new regulatory framework for active pharmaceutical ingredients comprises three resolutions edited by the National Health Surveillance Agency, the RDC No. 359, of March 27, 2020, the RDC No. 361, of April 1, 2020, and the RDC No. 672, of March 30, 2022.These regulations start new approaches to regularize the active pharmaceutical ingredient in the country. Objective: To demonstrate how the internalization of the legal and health requirements established by the new regulatory framework for active ingredients was absorbed and implemented by Farmanguinhos, an Official Pharmaceutical Laboratory. Method: Descriptive cross-sectional study based on data collection from the legal framework edited by the Brazilian Health Regulatory Agency, and the practical experience of Farmanguinhos, the main medicines supplier to the Ministry of Health. Results: The main result of this study was the survey of the needs for the implementation of the new framework by the Official Pharmaceutical Laboratories, observing the greater sanitary and regulatory rigor imposed on manufacturers of active ingredients and the reflection of this in the proposed adequacy of operational procedures at Farmanguinhos. Conclusions: This study concludes that it is up to the Official Pharmaceutical Laboratories to intermediate and act as facilitators in the relations between active pharmaceutical ingredients manufacturers, by reviewing their procedures and editing support tools, leading to the incorporation of requirements and, in parallel, facilitating the optimization of activities and actions aimed at the implementation of a new regulatory reality, both internally and by the manufacturers of inputs. |
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Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023Análise do novo marco regulatório de insumos farmacêuticos ativos no Brasil: a experiência de um laboratório farmacêutico oficial: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Publicado em: 17/08/2023Insumo Farmacêutico AtivoAgência Nacional de Vigilância SanitáriaLaboratório Farmacêutico OficialMarco RegulatórioActive Pharmaceutical IngredientBrazilian Health Regulatory AgencyOfficial Pharmaceutical LaboratoryRegulatory FrameworkIntroduction: The new regulatory framework for active pharmaceutical ingredients comprises three resolutions edited by the National Health Surveillance Agency, the RDC No. 359, of March 27, 2020, the RDC No. 361, of April 1, 2020, and the RDC No. 672, of March 30, 2022.These regulations start new approaches to regularize the active pharmaceutical ingredient in the country. Objective: To demonstrate how the internalization of the legal and health requirements established by the new regulatory framework for active ingredients was absorbed and implemented by Farmanguinhos, an Official Pharmaceutical Laboratory. Method: Descriptive cross-sectional study based on data collection from the legal framework edited by the Brazilian Health Regulatory Agency, and the practical experience of Farmanguinhos, the main medicines supplier to the Ministry of Health. Results: The main result of this study was the survey of the needs for the implementation of the new framework by the Official Pharmaceutical Laboratories, observing the greater sanitary and regulatory rigor imposed on manufacturers of active ingredients and the reflection of this in the proposed adequacy of operational procedures at Farmanguinhos. Conclusions: This study concludes that it is up to the Official Pharmaceutical Laboratories to intermediate and act as facilitators in the relations between active pharmaceutical ingredients manufacturers, by reviewing their procedures and editing support tools, leading to the incorporation of requirements and, in parallel, facilitating the optimization of activities and actions aimed at the implementation of a new regulatory reality, both internally and by the manufacturers of inputs.Introdução: O novo marco regulatório de insumos farmacêuticos ativos compreende três resoluções editadas pela Agência Nacional de Vigilância Sanitária em 2020, RDC nº 359, RDC nº 361 e RDC nº 672, inaugurando novas abordagens para regularização do insumo farmacêutico ativo no país. Objetivo: Demonstrar como a internalização dos requisitos legais e sanitários instituídos pelo novo marco regulatório de insumos ativos foi absorvida e implementada por Farmanguinhos, um laboratório farmacêutico oficial. Método: Estudo transversal descritivo com base no levantamento de dados do arcabouço legal editado pela Agência Nacional de Vigilância Sanitária e a experiência prática de Farmanguinhos, o principal laboratório público fornecedor de medicamentos ao Ministério da Saúde. Resultados: O principal resultado deste estudo foi o levantamento das necessidades para implementação do novo marco pelos laboratórios farmacêuticos oficiais, observando o maior rigor sanitário e regulatório imposto aos fabricantes de insumos ativos e a reflexão deste na proposta de adequação dos procedimentos operacionais de Farmanguinhos. Conclusões: Cabe aos laboratórios farmacêuticos oficiais intermediar e atuar como facilitadores nas relações entre fabricantes de insumo farmacêutico ativo e autoridade sanitária. Assim, eles exercem um papel de impulsionador no estreitamento da relação com os fabricantes de insumos, por meio da revisão de seus procedimentos e edição de instrumentos de apoio, conduzindo a incorporação das exigências e em paralelo facilitando a otimização das atividades e ações voltadas à implementação da nova realidade regulatória, tanto internamente quanto pelos fabricantes de insumos.Instituto Nacional de Controle de Qualidade em Saúde2023-08-17info: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/216110.22239/2317-269x.02161Health Surveillance under Debate: Society, Science & Technology ; v. 11 (2023) | Continuous publication; 1-10Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-10Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-102317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2161/1513https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2161/1583Copyright (c) 2023 Soraya Mileti da Costa, Maria Helena Simões Villas Boas, Priscila da Nobrega Rito (Autor)https://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessMileti da Costa, SorayaSimões Villas Boas, Maria Helenada Nobrega Rito, Priscila2024-02-21T17:42:23Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/2161Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2024-02-21T17:42:23Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 Análise do novo marco regulatório de insumos farmacêuticos ativos no Brasil: a experiência de um laboratório farmacêutico oficial: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Publicado em: 17/08/2023 |
title |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
spellingShingle |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 Mileti da Costa, Soraya Insumo Farmacêutico Ativo Agência Nacional de Vigilância Sanitária Laboratório Farmacêutico Oficial Marco Regulatório Active Pharmaceutical Ingredient Brazilian Health Regulatory Agency Official Pharmaceutical Laboratory Regulatory Framework |
title_short |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
title_full |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
title_fullStr |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
title_full_unstemmed |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
title_sort |
Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience: Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023 |
author |
Mileti da Costa, Soraya |
author_facet |
Mileti da Costa, Soraya Simões Villas Boas, Maria Helena da Nobrega Rito, Priscila |
author_role |
author |
author2 |
Simões Villas Boas, Maria Helena da Nobrega Rito, Priscila |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Mileti da Costa, Soraya Simões Villas Boas, Maria Helena da Nobrega Rito, Priscila |
dc.subject.por.fl_str_mv |
Insumo Farmacêutico Ativo Agência Nacional de Vigilância Sanitária Laboratório Farmacêutico Oficial Marco Regulatório Active Pharmaceutical Ingredient Brazilian Health Regulatory Agency Official Pharmaceutical Laboratory Regulatory Framework |
topic |
Insumo Farmacêutico Ativo Agência Nacional de Vigilância Sanitária Laboratório Farmacêutico Oficial Marco Regulatório Active Pharmaceutical Ingredient Brazilian Health Regulatory Agency Official Pharmaceutical Laboratory Regulatory Framework |
description |
Introduction: The new regulatory framework for active pharmaceutical ingredients comprises three resolutions edited by the National Health Surveillance Agency, the RDC No. 359, of March 27, 2020, the RDC No. 361, of April 1, 2020, and the RDC No. 672, of March 30, 2022.These regulations start new approaches to regularize the active pharmaceutical ingredient in the country. Objective: To demonstrate how the internalization of the legal and health requirements established by the new regulatory framework for active ingredients was absorbed and implemented by Farmanguinhos, an Official Pharmaceutical Laboratory. Method: Descriptive cross-sectional study based on data collection from the legal framework edited by the Brazilian Health Regulatory Agency, and the practical experience of Farmanguinhos, the main medicines supplier to the Ministry of Health. Results: The main result of this study was the survey of the needs for the implementation of the new framework by the Official Pharmaceutical Laboratories, observing the greater sanitary and regulatory rigor imposed on manufacturers of active ingredients and the reflection of this in the proposed adequacy of operational procedures at Farmanguinhos. Conclusions: This study concludes that it is up to the Official Pharmaceutical Laboratories to intermediate and act as facilitators in the relations between active pharmaceutical ingredients manufacturers, by reviewing their procedures and editing support tools, leading to the incorporation of requirements and, in parallel, facilitating the optimization of activities and actions aimed at the implementation of a new regulatory reality, both internally and by the manufacturers of inputs. |
publishDate |
2023 |
dc.date.none.fl_str_mv |
2023-08-17 |
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/2161 10.22239/2317-269x.02161 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2161 |
identifier_str_mv |
10.22239/2317-269x.02161 |
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/2161/1513 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/2161/1583 |
dc.rights.driver.fl_str_mv |
https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
rights_invalid_str_mv |
https://creativecommons.org/licenses/by/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 ; v. 11 (2023) | Continuous publication; 1-10 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; v. 11 (2023) | Publicación continua; 1-10 Vigil Sanit Debate, Rio de Janeiro; v. 11 (2023) | Publicação contínua; 1-10 2317-269X reponame:Vigilância Sanitária em Debate instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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Fundação Oswaldo Cruz (FIOCRUZ) |
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FIOCRUZ |
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FIOCRUZ |
reponame_str |
Vigilância Sanitária em Debate |
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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 |
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1797042047304073216 |