Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil
Autor(a) principal: | |
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Data de Publicação: | 2018 |
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/1078 |
Resumo: | Introduction: Advanced Therapy Medicinal Products (ATMP) have been a therapeutic promise for the treatment of several diseases, including those for which there is no therapeutic alternative available on the market. These products, obtained from human cells, were categorized internationally as a new therapeutic class with similar approach as biological medicines, although with different criteria, due to their peculiarities. Objective: This article aims to describe the history of the discussions and regulations published for the thematic, and to present the perspectives related to the development of the Brazilian regulatory framework for this new category of product, with the objective of providing a stable and transparent regulatory environment, favorable to the technological development at national level, as well as to attract national and international investments in the field. Method: The development of this article was based on the research of the history of normative published about the topic, on the regulatory initiatives implemented by Anvisa as well as on the participation of the authors in forums and discussions towards the theme. Results: Basis of the national regulatory framework for PTA to be elaborated, and exposure of the main aspects of the proposal. Conclusions: The proposal of regulatory framework for ATMP will cover the regulations for evaluation and approval of clinical trials by Anvisa, Certification of Good Cell Practices for producer establishments and marketing authorization of products. |
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Proposal of regulatory framework for Advanced Therapy Medicinal Products in BrazilProposta de marco regulatório para os Produtos de Terapias Avançadas no BrasilRegulamentaçãoCentro de Processamento CelularProdutos de Terapias AvançadasTerapia CelularMarco RegulatórioIntroduction: Advanced Therapy Medicinal Products (ATMP) have been a therapeutic promise for the treatment of several diseases, including those for which there is no therapeutic alternative available on the market. These products, obtained from human cells, were categorized internationally as a new therapeutic class with similar approach as biological medicines, although with different criteria, due to their peculiarities. Objective: This article aims to describe the history of the discussions and regulations published for the thematic, and to present the perspectives related to the development of the Brazilian regulatory framework for this new category of product, with the objective of providing a stable and transparent regulatory environment, favorable to the technological development at national level, as well as to attract national and international investments in the field. Method: The development of this article was based on the research of the history of normative published about the topic, on the regulatory initiatives implemented by Anvisa as well as on the participation of the authors in forums and discussions towards the theme. Results: Basis of the national regulatory framework for PTA to be elaborated, and exposure of the main aspects of the proposal. Conclusions: The proposal of regulatory framework for ATMP will cover the regulations for evaluation and approval of clinical trials by Anvisa, Certification of Good Cell Practices for producer establishments and marketing authorization of products.Introdução: Os Produtos de Terapias Avançadas (PTA) têm sido a grande promessa terapêutica para o tratamento de diversas doenças, inclusive aquelas para as quais não existe alternativa disponível no mercado. Estes produtos, obtidos a partir de células humanas,foram categorizados em âmbito internacional como nova classe terapêutica para a qual a regulamentação adotada assemelha-se à dos medicamentos biológicos, embora com abordagem e critérios diferenciados devido às peculiaridades dos PTA. Objetivo: O presente artigo tem como objetivos descrever o histórico das discussões e regulamentações editadas para a temática e apresentar as perspectivas relacionadas ao desenvolvimento do marco regulatório brasileiro para esta nova categoria de produto, a fim de propiciar um ambiente regulatório estável e transparente, favorável ao desenvolvimento tecnológico em âmbito nacional, bem como ao fomento através de investimentos nacionais e internacionais. Método: O desenvolvimento deste artigo baseou-se na pesquisa do histórico de normativos sobre o tema, nas iniciativas regulatórias adotadas pela Anvisa, bem como na experiência dos autores a partir de participação em fóruns e discussões afetas à área. Resultados: Fundamentação do marco regulatório sanitário nacional para PTA a ser elaborado, e exposição dos principais aspectos da proposta. Conclusões: A proposta de marco regulatório nacional para os PTAs abarcará regulamentos para avaliação e aprovação de ensaios clínicos pela Anvisa, Certificação de Boas Práticas em Células para estabelecimentos produtores e registro de produtos.Instituto Nacional de Controle de Qualidade em Saúde2018-02-28info: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/107810.22239/2317-269X.01078Health Surveillance under Debate: Society, Science & Technology ; Vol. 6 No. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-22Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-22Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-222317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1078/425https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1078/998Copyright (c) 2018 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/openAccessParca, Renata MirandaMendes Takao, Marilia RodriguesSilva Junior, João Batista da2023-06-27T15:07:41Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/1078Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:07:41Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false |
dc.title.none.fl_str_mv |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil Proposta de marco regulatório para os Produtos de Terapias Avançadas no Brasil |
title |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
spellingShingle |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil Parca, Renata Miranda Regulamentação Centro de Processamento Celular Produtos de Terapias Avançadas Terapia Celular Marco Regulatório |
title_short |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
title_full |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
title_fullStr |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
title_full_unstemmed |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
title_sort |
Proposal of regulatory framework for Advanced Therapy Medicinal Products in Brazil |
author |
Parca, Renata Miranda |
author_facet |
Parca, Renata Miranda Mendes Takao, Marilia Rodrigues Silva Junior, João Batista da |
author_role |
author |
author2 |
Mendes Takao, Marilia Rodrigues Silva Junior, João Batista da |
author2_role |
author author |
dc.contributor.author.fl_str_mv |
Parca, Renata Miranda Mendes Takao, Marilia Rodrigues Silva Junior, João Batista da |
dc.subject.por.fl_str_mv |
Regulamentação Centro de Processamento Celular Produtos de Terapias Avançadas Terapia Celular Marco Regulatório |
topic |
Regulamentação Centro de Processamento Celular Produtos de Terapias Avançadas Terapia Celular Marco Regulatório |
description |
Introduction: Advanced Therapy Medicinal Products (ATMP) have been a therapeutic promise for the treatment of several diseases, including those for which there is no therapeutic alternative available on the market. These products, obtained from human cells, were categorized internationally as a new therapeutic class with similar approach as biological medicines, although with different criteria, due to their peculiarities. Objective: This article aims to describe the history of the discussions and regulations published for the thematic, and to present the perspectives related to the development of the Brazilian regulatory framework for this new category of product, with the objective of providing a stable and transparent regulatory environment, favorable to the technological development at national level, as well as to attract national and international investments in the field. Method: The development of this article was based on the research of the history of normative published about the topic, on the regulatory initiatives implemented by Anvisa as well as on the participation of the authors in forums and discussions towards the theme. Results: Basis of the national regulatory framework for PTA to be elaborated, and exposure of the main aspects of the proposal. Conclusions: The proposal of regulatory framework for ATMP will cover the regulations for evaluation and approval of clinical trials by Anvisa, Certification of Good Cell Practices for producer establishments and marketing authorization of products. |
publishDate |
2018 |
dc.date.none.fl_str_mv |
2018-02-28 |
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/1078 10.22239/2317-269X.01078 |
url |
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1078 |
identifier_str_mv |
10.22239/2317-269X.01078 |
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/1078/425 https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1078/998 |
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. 6 No. 1 (2018): February - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-22 Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 6 Núm. 1 (2018): Febrero - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-22 Vigil Sanit Debate, Rio de Janeiro; v. 6 n. 1 (2018): Fevereiro - Tecnologias celulares avançadas: desafios biotecnológicos e regulatórios; 15-22 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_ |
1797042045223698432 |