Regulatory basis for the safety assessment of nanotechnology-based drug products

Detalhes bibliográficos
Autor(a) principal: Tobler, Juliana Palermo
Data de Publicação: 2020
Outros Autores: Rocha, Helvécio Vinícius Antunes
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/1358
Resumo: Introduction: Nanotechnology is a transdisciplinary technology that is being developed and applied in several areas, including health, especially in terms of therapy and diagnosis. However, the relationship between some of their physicochemical properties and their toxicological effects remains unclear. Therefore, it is necessary to understand whether the regulatory requirements, in terms of toxicological evaluation, for the registration of a nanotechnology-based drug, are able to identify the possible risks arising from this new technology. Objective: To compare the regulatory approach of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Brazilian Health Regulatory Agency (Anvisa) with respect to nanomedicine evaluation compared to conventional drugs evaluation. Method: Qualitative bibliographic research was performed in different databases and regulatory agencies websites. Results: Many limitations of the currently recommended tests have been demonstrated, and several are under review for better adaptation to the effect that may suffer by the evaluated nanoparticles themselves. Conclusions: Toxicological tests currently recommended by the regulatory agencies of the United States of America, the European Union and Brazil, although aligned, are not specific for the evaluation of nanomedicines.
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spelling Regulatory basis for the safety assessment of nanotechnology-based drug productsBases regulatórias para a avaliação da segurança de medicamentos à base de nanotecnologiaNanomedicineSafetyToxicologyRegulationAnvisaNanomedicinaSegurançaToxicologiaRegulamentaçãoAnvisaIntroduction: Nanotechnology is a transdisciplinary technology that is being developed and applied in several areas, including health, especially in terms of therapy and diagnosis. However, the relationship between some of their physicochemical properties and their toxicological effects remains unclear. Therefore, it is necessary to understand whether the regulatory requirements, in terms of toxicological evaluation, for the registration of a nanotechnology-based drug, are able to identify the possible risks arising from this new technology. Objective: To compare the regulatory approach of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Brazilian Health Regulatory Agency (Anvisa) with respect to nanomedicine evaluation compared to conventional drugs evaluation. Method: Qualitative bibliographic research was performed in different databases and regulatory agencies websites. Results: Many limitations of the currently recommended tests have been demonstrated, and several are under review for better adaptation to the effect that may suffer by the evaluated nanoparticles themselves. Conclusions: Toxicological tests currently recommended by the regulatory agencies of the United States of America, the European Union and Brazil, although aligned, are not specific for the evaluation of nanomedicines.Introdução: A nanotecnologia é uma tecnologia transdisciplinar que está sendo desenvolvida e aplicada em diversas áreas, dentre as quais cabe ressaltar a da saúde, principalmente no que tange à terapêutica e ao diagnóstico. Entretanto, ainda não se tem clara a relação entre algumas de suas propriedades físico-químicas e seus efeitos toxicológicos. Por isso, é necessário entender se os requisitos regulatórios, em termos de avaliação toxicológica, para registro de um medicamento com base em nanotecnologia, são capazes de identificar os possíveis riscos advindos desta nova tecnologia. Objetivo: Comparar a abordagem regulatória da US Food and Drug Administration (FDA), da European Medicines Agency (EMA) e da Agêcom medicamentos convencionais. Método: Foi realizada pesquisa bibliográfica qualitativa em diferentes bases de dados e agências regulatórias. Resultados: Foram demonstradas muitas limitações dos testes atualmentncia Nacional de Vigilância Sanitária (Anvisa) com relação à avaliação de nanomedicamentos em comparação e preconizados, sendo que diversos deles encontram-se em caráter de revisão para melhor adequação ao efeito que podem sofrer pelas próprias nanopartículas avaliadas. Conclusões: Testes toxicológicos preconizados atualmente pelas agências reguladoras dos Estados Unidos da América, da União Europeia e do Brasil, apesar de estarem alinhados, não são específicos para a avaliação de nanomedicamentos.Instituto Nacional de Controle de Qualidade em Saúde2020-05-28info: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/135810.22239/2317-269X.01358Health Surveillance under Debate: Society, Science & Technology ; Vol. 8 No. 2 (2020): May; 64-74Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 8 Núm. 2 (2020): Puede; 64-74Vigil Sanit Debate, Rio de Janeiro; v. 8 n. 2 (2020): Maio; 64-742317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1358/1167https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1358/1211Copyright (c) 2020 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/openAccessTobler, Juliana PalermoRocha, Helvécio Vinícius Antunes2023-06-27T15:12:27Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1358Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:12:27Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Regulatory basis for the safety assessment of nanotechnology-based drug products
Bases regulatórias para a avaliação da segurança de medicamentos à base de nanotecnologia
title Regulatory basis for the safety assessment of nanotechnology-based drug products
spellingShingle Regulatory basis for the safety assessment of nanotechnology-based drug products
Tobler, Juliana Palermo
Nanomedicine
Safety
Toxicology
Regulation
Anvisa
Nanomedicina
Segurança
Toxicologia
Regulamentação
Anvisa
title_short Regulatory basis for the safety assessment of nanotechnology-based drug products
title_full Regulatory basis for the safety assessment of nanotechnology-based drug products
title_fullStr Regulatory basis for the safety assessment of nanotechnology-based drug products
title_full_unstemmed Regulatory basis for the safety assessment of nanotechnology-based drug products
title_sort Regulatory basis for the safety assessment of nanotechnology-based drug products
author Tobler, Juliana Palermo
author_facet Tobler, Juliana Palermo
Rocha, Helvécio Vinícius Antunes
author_role author
author2 Rocha, Helvécio Vinícius Antunes
author2_role author
dc.contributor.author.fl_str_mv Tobler, Juliana Palermo
Rocha, Helvécio Vinícius Antunes
dc.subject.por.fl_str_mv Nanomedicine
Safety
Toxicology
Regulation
Anvisa
Nanomedicina
Segurança
Toxicologia
Regulamentação
Anvisa
topic Nanomedicine
Safety
Toxicology
Regulation
Anvisa
Nanomedicina
Segurança
Toxicologia
Regulamentação
Anvisa
description Introduction: Nanotechnology is a transdisciplinary technology that is being developed and applied in several areas, including health, especially in terms of therapy and diagnosis. However, the relationship between some of their physicochemical properties and their toxicological effects remains unclear. Therefore, it is necessary to understand whether the regulatory requirements, in terms of toxicological evaluation, for the registration of a nanotechnology-based drug, are able to identify the possible risks arising from this new technology. Objective: To compare the regulatory approach of US Food and Drug Administration (FDA), European Medicines Agency (EMA) and Brazilian Health Regulatory Agency (Anvisa) with respect to nanomedicine evaluation compared to conventional drugs evaluation. Method: Qualitative bibliographic research was performed in different databases and regulatory agencies websites. Results: Many limitations of the currently recommended tests have been demonstrated, and several are under review for better adaptation to the effect that may suffer by the evaluated nanoparticles themselves. Conclusions: Toxicological tests currently recommended by the regulatory agencies of the United States of America, the European Union and Brazil, although aligned, are not specific for the evaluation of nanomedicines.
publishDate 2020
dc.date.none.fl_str_mv 2020-05-28
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/1358
10.22239/2317-269X.01358
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1358
identifier_str_mv 10.22239/2317-269X.01358
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/1358/1167
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1358/1211
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. 8 No. 2 (2020): May; 64-74
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 8 Núm. 2 (2020): Puede; 64-74
Vigil Sanit Debate, Rio de Janeiro; v. 8 n. 2 (2020): Maio; 64-74
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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