Regulatory basis for the safety assessment of nanotechnology-based drug products
Autor(a) principal: | |
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Data de Publicação: | 2020 |
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/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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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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1797042045430267904 |