Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?

Detalhes bibliográficos
Autor(a) principal: Matos, Allan Weberling
Data de Publicação: 2017
Tipo de documento: Artigo
Idioma: por
Título da fonte: Cadernos Ibero-Americanos de Direito Sanitário (Online)
Texto Completo: https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420
Resumo: Objective: to verify if the delay in Brazil to decide about marketing authorization applications of new and generic drugs meets the new legal deadlines, according to the review type as standard or priority review. Methods: a survey was carried out of the applications for which the decision by Brazilian Health Regulatory Agency (ANVISA) was made in the years 2015 and 2016. Afterwards the information to determine the delay of Agency’s responsibility (to begin analysis and the duration of this) and the delay of company’s responsibility (for clarification) were collected. Results: the time practiced by ANVISA in all cases still exceeds the legal limit, but considering the possibility of extending the deadline by up to one third, only the group of generic drugs with standard assessment would be far from the goal. Conclusion: the duration of the assessment is reasonable, but the backlog of applications and the waiting period for assessment are one of the main obstacles for Brazilian authority to meet the deadlines, especially about non-prioritized generic drugs. In addition, it will also be challenging for the Agency to assessment the prioritized new drugs applications within 120 days, given the novelty of these products and the complexity of the documentation being greater than the other drug products.
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spelling Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?Decisiones relativas a peticiones de registro de medicamentos nuevos y genéricos en Brasil: los plazos fijados en la Ley 13.411/2016 son factibles?Decisões acerca de petições de registro de medicamentos novos, similares e genéricos no Brasil: os prazos fixados na Lei 13.411/2016 são factíveis?TimeProducts RegistrationDrugsTiempoRegistro de ProductosMedicamentosTempoRegistro de ProdutosMedicamentosObjective: to verify if the delay in Brazil to decide about marketing authorization applications of new and generic drugs meets the new legal deadlines, according to the review type as standard or priority review. Methods: a survey was carried out of the applications for which the decision by Brazilian Health Regulatory Agency (ANVISA) was made in the years 2015 and 2016. Afterwards the information to determine the delay of Agency’s responsibility (to begin analysis and the duration of this) and the delay of company’s responsibility (for clarification) were collected. Results: the time practiced by ANVISA in all cases still exceeds the legal limit, but considering the possibility of extending the deadline by up to one third, only the group of generic drugs with standard assessment would be far from the goal. Conclusion: the duration of the assessment is reasonable, but the backlog of applications and the waiting period for assessment are one of the main obstacles for Brazilian authority to meet the deadlines, especially about non-prioritized generic drugs. In addition, it will also be challenging for the Agency to assessment the prioritized new drugs applications within 120 days, given the novelty of these products and the complexity of the documentation being greater than the other drug products.Objetivo: verificar si el tiempo gastado en Brasil para emitir decisión sobre pedidos de registro de medicamentos nuevos y genéricos atiende a los nuevos plazos legales, considerando el encuadramiento en las categorías de análisis ordinario y prioritario. Métodos: mediante el levantamiento de las peticiones cuya decisión de la Agencia Brasileña de Regulación de la Salud (ANVISA) fue publicada en los años 2015 y 2016, se recolecta información para determinar los tiempos de responsabilidad de la Agencia (para iniciar el análisis y la duración de ésta) y de las empresas solicitantes (para el envío de aclaraciones). Resultados: el tiempo practicado por la ANVISA en todos los casos aún supera el límite legal, pero considerando la posibilidad de extender el plazo hasta en un tercio, sólo el grupo de medicamentos genéricos analizados por el rito ordinario estaría lejos de la meta. Conclusión: la duración del análisis es razonable, pero el pasivo de peticiones y el período que esperan por evaluación son uno de los principales impedimentos para que la autoridad brasileña consiga cumplir los plazos, principalmente con relación a los genéricos no priorizados. Además, también será desafiante para la Agencia el análisis en hasta 120 días de los procesos de medicamentos nuevos priorizados, dada la novedad de estos productos y la complejidad de la documentación ser mayor que la de los demás medicamentos.RESUMO. Objetivo: verificar se o tempo despendido no Brasil para emitir decisão sobre pedidos de registro de medicamentos novos, similares e genéricos atende aos novos prazos legais, considerando o enquadramento nas categorias de análise ordinária e prioritária. Métodos: mediante levantamento das petições cuja decisão da Agência Nacional de Vigilância Sanitária (ANVISA) foi publicada nos anos de 2015 e 2016, foram coletadas informações para determinação dos tempos de responsabilidade da Agência (para iniciar análise e a duração dessa) e das empresas requerentes (para envio de esclarecimentos). Resultados: o tempo praticado pela ANVISA em todos os casos ainda ultrapassa o limite legal, mas, se considerada a possibilidade de prorrogação em até um terço, apenas o grupo de medicamentos genéricos e similares analisados pelo rito ordinário estaria longe da meta. Conclusão: a duração da análise é razoável, mas o passivo de petições e o período que elas aguardam por avaliação são uns dos principais impedimentos para que a autoridade brasileira consiga cumprir os prazos, principalmente com relação aos genéricos e similares não priorizados; além disso, também será desafiador para a Agência a análise, em até 120 dias, dos processos de medicamentos novos priorizados, dado o ineditismo desses produtos e a complexidade da documentação ser maior que a dos demais medicamentos.Fundação Oswaldo Cruz Brasília2017-12-28info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/vnd.openxmlformats-officedocument.wordprocessingml.documenthttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/42010.17566/ciads.v6i4.420Iberoamerican Journal of Health Law; Vol. 6 No. 4 (2017): (OUT/DEZ.2017); 147-168Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 6 Núm. 4 (2017): (OUT/DEZ.2017); 147-168Cadernos Ibero-Americanos de Direito Sanitário; v. 6 n. 4 (2017): (OUT/DEZ.2017); 147-1682358-18242317-839610.17566/ciads.v6i4reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420/495https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420/66410.17566/ciads.v6i4.420.s81Copyright (c) 2017 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIOinfo:eu-repo/semantics/openAccessMatos, Allan Weberling2020-03-24T20:46:36Zoai:ojs.cadernos.prodisa.fiocruz.br:article/420Revistahttp://www.cadernos.prodisa.fiocruz.brPUBhttp://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/oaicadernos.direitosanitario@fiocruz.br2358-18242317-8396opendoar:2020-03-24T20:46:36Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
Decisiones relativas a peticiones de registro de medicamentos nuevos y genéricos en Brasil: los plazos fijados en la Ley 13.411/2016 son factibles?
Decisões acerca de petições de registro de medicamentos novos, similares e genéricos no Brasil: os prazos fixados na Lei 13.411/2016 são factíveis?
title Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
spellingShingle Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
Matos, Allan Weberling
Time
Products Registration
Drugs
Tiempo
Registro de Productos
Medicamentos
Tempo
Registro de Produtos
Medicamentos
title_short Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
title_full Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
title_fullStr Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
title_full_unstemmed Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
title_sort Decisions about new and generic drugs marketing authorization applications in Brazil: are the deadlines defined by Law 13.411/2016 practicable?
author Matos, Allan Weberling
author_facet Matos, Allan Weberling
author_role author
dc.contributor.author.fl_str_mv Matos, Allan Weberling
dc.subject.por.fl_str_mv Time
Products Registration
Drugs
Tiempo
Registro de Productos
Medicamentos
Tempo
Registro de Produtos
Medicamentos
topic Time
Products Registration
Drugs
Tiempo
Registro de Productos
Medicamentos
Tempo
Registro de Produtos
Medicamentos
description Objective: to verify if the delay in Brazil to decide about marketing authorization applications of new and generic drugs meets the new legal deadlines, according to the review type as standard or priority review. Methods: a survey was carried out of the applications for which the decision by Brazilian Health Regulatory Agency (ANVISA) was made in the years 2015 and 2016. Afterwards the information to determine the delay of Agency’s responsibility (to begin analysis and the duration of this) and the delay of company’s responsibility (for clarification) were collected. Results: the time practiced by ANVISA in all cases still exceeds the legal limit, but considering the possibility of extending the deadline by up to one third, only the group of generic drugs with standard assessment would be far from the goal. Conclusion: the duration of the assessment is reasonable, but the backlog of applications and the waiting period for assessment are one of the main obstacles for Brazilian authority to meet the deadlines, especially about non-prioritized generic drugs. In addition, it will also be challenging for the Agency to assessment the prioritized new drugs applications within 120 days, given the novelty of these products and the complexity of the documentation being greater than the other drug products.
publishDate 2017
dc.date.none.fl_str_mv 2017-12-28
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
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dc.identifier.uri.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420
10.17566/ciads.v6i4.420
url https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420
identifier_str_mv 10.17566/ciads.v6i4.420
dc.language.iso.fl_str_mv por
language por
dc.relation.none.fl_str_mv https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420/495
https://www.cadernos.prodisa.fiocruz.br/index.php/cadernos/article/view/420/664
10.17566/ciads.v6i4.420.s81
dc.rights.driver.fl_str_mv Copyright (c) 2017 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
info:eu-repo/semantics/openAccess
rights_invalid_str_mv Copyright (c) 2017 CADERNOS IBERO-AMERICANOS DE DIREITO SANITÁRIO
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/vnd.openxmlformats-officedocument.wordprocessingml.document
dc.publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
publisher.none.fl_str_mv Fundação Oswaldo Cruz Brasília
dc.source.none.fl_str_mv Iberoamerican Journal of Health Law; Vol. 6 No. 4 (2017): (OUT/DEZ.2017); 147-168
Cuadernos Iberoamericanos de Derecho Sanitario; Vol. 6 Núm. 4 (2017): (OUT/DEZ.2017); 147-168
Cadernos Ibero-Americanos de Direito Sanitário; v. 6 n. 4 (2017): (OUT/DEZ.2017); 147-168
2358-1824
2317-8396
10.17566/ciads.v6i4
reponame:Cadernos Ibero-Americanos de Direito Sanitário (Online)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Cadernos Ibero-Americanos de Direito Sanitário (Online)
collection Cadernos Ibero-Americanos de Direito Sanitário (Online)
repository.name.fl_str_mv Cadernos Ibero-Americanos de Direito Sanitário (Online) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv cadernos.direitosanitario@fiocruz.br
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