Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil
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Data de Publicação: | 2015 |
Outros Autores: | , |
Tipo de documento: | Artigo |
Idioma: | por |
Título da fonte: | Vigilância Sanitária em Debate |
Texto Completo: | https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439 |
Resumo: | The aim of the study was to investigate the potential contribution that the obligatory registration of active pharmaceutical ingredients (APIs) had on the establishment of regulatory isonomy between API producers in Brazil and international producers. In addition, this study aimed to evaluate the effect of this isonomy on the re-establishment of local production. The investigation identified the registration of 20 APIs, defined as priorities by the Brazilian National Agency for the Sanitary Surveillance (ANVISA), in the period 2010–2012. The methodology used included the collection of data from national and international, public and private, databases that allowed the construction of tables and graphs. The results demonstrated that registration of APIs is an important instrument for public politics leading to regulatory isonomy. However, the period under analysis was not sufficiently long to confirm that the RDC, combined with other governmental actions, may have promoted the increase in production, although some signs exist that this will eventually happen. |
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Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in BrazilRegistro de insumos farmacêuticos ativos: impactos e reflexos sobre as indústrias farmoquímica e farmacêutica instaladas no BrasilInsumoIsonomiaFabricaçãoImportaçãoRegistroActiveIsonomyProductionImportationRegistrationThe aim of the study was to investigate the potential contribution that the obligatory registration of active pharmaceutical ingredients (APIs) had on the establishment of regulatory isonomy between API producers in Brazil and international producers. In addition, this study aimed to evaluate the effect of this isonomy on the re-establishment of local production. The investigation identified the registration of 20 APIs, defined as priorities by the Brazilian National Agency for the Sanitary Surveillance (ANVISA), in the period 2010–2012. The methodology used included the collection of data from national and international, public and private, databases that allowed the construction of tables and graphs. The results demonstrated that registration of APIs is an important instrument for public politics leading to regulatory isonomy. However, the period under analysis was not sufficiently long to confirm that the RDC, combined with other governmental actions, may have promoted the increase in production, although some signs exist that this will eventually happen.O presente estudo teve por objetivo investigar e avaliar a potencial contribuição que a obrigatoriedade do registro de Insumos Farmacêuticos Ativos (IFAs) teve no estabelecimento da isonomia regulatória entre o fabricante de IFA no Brasil e o fabricante internacional e a efetividade que essa isonomia teve no restabelecimento da produção local desses produtos. A pesquisa levou à identificação dos registros dos 20 IFAs, definidos como prioritários pela Agência Nacional de Vigilância Sanitária (ANVISA), no período 2010-2012. A metodologia utilizada compreendeu o levantamento de dados de bases nacionais e internacionais, públicas e privadas, que possibilitaram a construção de tabelas e gráficos, levando às informações da pesquisa. Os resultados demonstraram que o registro do IFA é um importante instrumento de política pública na obtenção da isonomia regulatória. Porém, o tempo de análise não foi suficientemente longo para assegurar que a mesma, associada a outras ações do governo para o incentivo à produção local de IFAs, tenha sido capaz de promover o aumento da fabricação desses produtos, apesar de haver sinalizações de que isso acontecerá.Instituto Nacional de Controle de Qualidade em Saúde2015-05-29info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documentapplication/vnd.openxmlformats-officedocument.wordprocessingml.documenthttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/43910.3395/2317-269x.00439Health Surveillance under Debate: Society, Science & Technology ; Vol. 3 No. 2 (2015): May; 9-19Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 2 (2015): Puede; 9-19Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 2 (2015): Maio; 9-192317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/224https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/676https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/677Copyright (c) 2015 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/openAccessArrepia, Diva BarrioCosta, Jorge CarlosTabak, David2023-06-27T14:59:48Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/439Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T14:59:48Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil Registro de insumos farmacêuticos ativos: impactos e reflexos sobre as indústrias farmoquímica e farmacêutica instaladas no Brasil |
title |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
spellingShingle |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil Arrepia, Diva Barrio Insumo Isonomia Fabricação Importação Registro Active Isonomy Production Importation Registration |
title_short |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
title_full |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
title_fullStr |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
title_full_unstemmed |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
title_sort |
Registration of active pharmaceutical Ingredients: impacts and repercussions on the pharmochemical and pharmaceutical industries in Brazil |
author |
Arrepia, Diva Barrio |
author_facet |
Arrepia, Diva Barrio Costa, Jorge Carlos Tabak, David |
author_role |
author |
author2 |
Costa, Jorge Carlos Tabak, David |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Arrepia, Diva Barrio Costa, Jorge Carlos Tabak, David |
dc.subject.por.fl_str_mv |
Insumo Isonomia Fabricação Importação Registro Active Isonomy Production Importation Registration |
topic |
Insumo Isonomia Fabricação Importação Registro Active Isonomy Production Importation Registration |
description |
The aim of the study was to investigate the potential contribution that the obligatory registration of active pharmaceutical ingredients (APIs) had on the establishment of regulatory isonomy between API producers in Brazil and international producers. In addition, this study aimed to evaluate the effect of this isonomy on the re-establishment of local production. The investigation identified the registration of 20 APIs, defined as priorities by the Brazilian National Agency for the Sanitary Surveillance (ANVISA), in the period 2010–2012. The methodology used included the collection of data from national and international, public and private, databases that allowed the construction of tables and graphs. The results demonstrated that registration of APIs is an important instrument for public politics leading to regulatory isonomy. However, the period under analysis was not sufficiently long to confirm that the RDC, combined with other governmental actions, may have promoted the increase in production, although some signs exist that this will eventually happen. |
publishDate |
2015 |
dc.date.none.fl_str_mv |
2015-05-29 |
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/439 10.3395/2317-269x.00439 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439 |
identifier_str_mv |
10.3395/2317-269x.00439 |
dc.language.iso.fl_str_mv |
por |
language |
por |
dc.relation.none.fl_str_mv |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/224 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/676 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/439/677 |
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/vnd.openxmlformats-officedocument.wordprocessingml.document application/vnd.openxmlformats-officedocument.wordprocessingml.document |
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. 3 No. 2 (2015): May; 9-19 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 3 Núm. 2 (2015): Puede; 9-19 Vigil Sanit Debate, Rio de Janeiro; v. 3 n. 2 (2015): Maio; 9-19 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 |
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1797042044113256448 |