Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations
Autor(a) principal: | |
---|---|
Data de Publicação: | 2014 |
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/399 |
Resumo: | The use of genetically modified plants to synthesize proteins that are subsequently processed, regulated, and sold as pharmaceuticals is already a global reality. However, the issue of technological development and industrial production of biological products being expressed in transgenic plants and their impact on the safety of the food chain needs to be discussed more deeply. In this paper, we present an extensive literature review on the standards and regulatory guidelines as well as on biosafety in Brazil with regard to the production of plant-made pharmaceuticals; compare them with the regulatory guidelines of other countries/regions such as USA, Canada, European Union, Cuba, and Argentina; and analyze gaps in the Brazilian regulation. . We suggest that some regulations must be reviewed and conclude that the Brazilian regulatory authorities should establish an interrelated regulatory framework together, which would enable industrial production while protecting human and animal health as well as the environment. |
id |
FIOCRUZ-9_d388bed4e10abb7084946fbc580a1abb |
---|---|
oai_identifier_str |
oai:ojs.visaemdebate.incqs.fiocruz.br:article/399 |
network_acronym_str |
FIOCRUZ-9 |
network_name_str |
Vigilância Sanitária em Debate |
repository_id_str |
|
spelling |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulationsProdução de biológicos em plataformas vegetais e seus impactos na segurança alimentar – análise de lacunas na regulação vigenteGenetically Modified PlantsPlant-made PharmaceuticalsFood SecurityRegulationGap AnalysisPlantas Geneticamente ModificadasPlantas Produtoras de BiológicosSegurança AlimentarRegulaçãoAnálise de LacunasThe use of genetically modified plants to synthesize proteins that are subsequently processed, regulated, and sold as pharmaceuticals is already a global reality. However, the issue of technological development and industrial production of biological products being expressed in transgenic plants and their impact on the safety of the food chain needs to be discussed more deeply. In this paper, we present an extensive literature review on the standards and regulatory guidelines as well as on biosafety in Brazil with regard to the production of plant-made pharmaceuticals; compare them with the regulatory guidelines of other countries/regions such as USA, Canada, European Union, Cuba, and Argentina; and analyze gaps in the Brazilian regulation. . We suggest that some regulations must be reviewed and conclude that the Brazilian regulatory authorities should establish an interrelated regulatory framework together, which would enable industrial production while protecting human and animal health as well as the environment.O uso de plantas geneticamente modificadas (GM) para sintetizar proteínas que são posteriormente processadas, reguladas e vendidas como medicamentos já é uma realidade mundial. No entanto, a questão do desenvolvimento tecnológico e a produção industrial de produtos biológicos sendo expressos em plantas transgênicas e seu impacto na segurança da cadeia alimentar necessitam ser discutidas mais profundamente. Neste artigo, foi realizada uma extensa revisão bibliográfica nas normas e diretrizes regulatórias e de biossegurança do Brasil que tratam da produção de biológicos em plataformas vegetais, foi feita uma comparação com a regulação de outros países como Estados Unidos, Canadá, União Europeia, Cuba e Argentina e uma análise das lacunas existentes na regulação brasileira. Sugerimos que algumas regulações sejam revisadas e concluímos que as entidades regulatórias brasileiras devem estabelecer um arcabouço regulatório conjunto e interrelacionado que permita a produção industrial mantendo, todavia, a proteção à saúde humana e animal e a proteção ao meio ambiente.Instituto Nacional de Controle de Qualidade em Saúde2014-11-27info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersion"Peer-reviewed article""Artículo revisado por pares""Artigo avaliado pelos pares"application/pdfhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/39910.3395/vd.v2n4.399Health Surveillance under Debate: Society, Science & Technology ; Vol. 2 No. 4 (2014): November - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-85Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 4 (2014): Noviembre - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-85Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 4 (2014): Novembro - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-852317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/399/168Copyright (c) 2014 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/openAccessGuimarães, Rosane CuberFreire, Marcos da Silvade Almeida, Antonio Eugenio Castro Cardoso2023-06-27T15:08:08Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/399Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:08:08Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations Produção de biológicos em plataformas vegetais e seus impactos na segurança alimentar – análise de lacunas na regulação vigente |
title |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
spellingShingle |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations Guimarães, Rosane Cuber Genetically Modified Plants Plant-made Pharmaceuticals Food Security Regulation Gap Analysis Plantas Geneticamente Modificadas Plantas Produtoras de Biológicos Segurança Alimentar Regulação Análise de Lacunas |
title_short |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
title_full |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
title_fullStr |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
title_full_unstemmed |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
title_sort |
Plant-made pharmaceuticals and their impact on food security: Gap analysis of the current regulations |
author |
Guimarães, Rosane Cuber |
author_facet |
Guimarães, Rosane Cuber Freire, Marcos da Silva de Almeida, Antonio Eugenio Castro Cardoso |
author_role |
author |
author2 |
Freire, Marcos da Silva de Almeida, Antonio Eugenio Castro Cardoso |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Guimarães, Rosane Cuber Freire, Marcos da Silva de Almeida, Antonio Eugenio Castro Cardoso |
dc.subject.por.fl_str_mv |
Genetically Modified Plants Plant-made Pharmaceuticals Food Security Regulation Gap Analysis Plantas Geneticamente Modificadas Plantas Produtoras de Biológicos Segurança Alimentar Regulação Análise de Lacunas |
topic |
Genetically Modified Plants Plant-made Pharmaceuticals Food Security Regulation Gap Analysis Plantas Geneticamente Modificadas Plantas Produtoras de Biológicos Segurança Alimentar Regulação Análise de Lacunas |
description |
The use of genetically modified plants to synthesize proteins that are subsequently processed, regulated, and sold as pharmaceuticals is already a global reality. However, the issue of technological development and industrial production of biological products being expressed in transgenic plants and their impact on the safety of the food chain needs to be discussed more deeply. In this paper, we present an extensive literature review on the standards and regulatory guidelines as well as on biosafety in Brazil with regard to the production of plant-made pharmaceuticals; compare them with the regulatory guidelines of other countries/regions such as USA, Canada, European Union, Cuba, and Argentina; and analyze gaps in the Brazilian regulation. . We suggest that some regulations must be reviewed and conclude that the Brazilian regulatory authorities should establish an interrelated regulatory framework together, which would enable industrial production while protecting human and animal health as well as the environment. |
publishDate |
2014 |
dc.date.none.fl_str_mv |
2014-11-27 |
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/399 10.3395/vd.v2n4.399 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/399 |
identifier_str_mv |
10.3395/vd.v2n4.399 |
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/399/168 |
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 |
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. 2 No. 4 (2014): November - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-85 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 2 Núm. 4 (2014): Noviembre - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-85 Vigil Sanit Debate, Rio de Janeiro; v. 2 n. 4 (2014): Novembro - Vigilância Sanitária e a Promoção da Alimentação Adequada e Saudável: Impasses, Desafios e Perspectivas; 76-85 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_ |
1797042044072361984 |