Main non-technical reasons to refuse pharmaceutical drug products registration in 2015

Detalhes bibliográficos
Autor(a) principal: do Carmo, Ana Cerúlia Moraes
Data de Publicação: 2017
Outros Autores: Nogueira, Ellen, Gratieri, Tais
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/835
Resumo: The registration of pharmaceutical drug products involves reviewing company’s administrative aspects as well as technical-scientific aspects related to efficacy, safety and quality. This study evaluated the main administrative reasons for registration refusals of new, generic and similar (branded generic) pharmaceutical drug products in Brazil. Actual submission procedure and process instruction is presented in detail. The aim is to contribute for the improvement of novel applications, reducing non-technical refusals. A retrospective search of registration refusals in 2015 published by the Brazilian Government Official Gazette using Anvisa database, called Datavisa, was performed. The main reasons for non-technical registration refusals of generic and similar pharmaceutical drug products were deadline non-compliance (61.7%), preliminary review (19.8%) and insufficient documentation to permit a substantial full review (18.5%). Disclosure of administrative reasons behind failed applications is a step forward on regulatory transparency, and on internal and external orientation about regulatory mechanisms.
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spelling Main non-technical reasons to refuse pharmaceutical drug products registration in 2015Principais razões não técnicas para o indeferimento de registro de medicamentos em 2015AnvisaRegistro de MedicamentoMedicamento GenéricoMedicamento SimilarVigilância SanitáriaAnvisaProducts RegistrationGeneric DrugSimilar DrugSanitary SurveillanceThe registration of pharmaceutical drug products involves reviewing company’s administrative aspects as well as technical-scientific aspects related to efficacy, safety and quality. This study evaluated the main administrative reasons for registration refusals of new, generic and similar (branded generic) pharmaceutical drug products in Brazil. Actual submission procedure and process instruction is presented in detail. The aim is to contribute for the improvement of novel applications, reducing non-technical refusals. A retrospective search of registration refusals in 2015 published by the Brazilian Government Official Gazette using Anvisa database, called Datavisa, was performed. The main reasons for non-technical registration refusals of generic and similar pharmaceutical drug products were deadline non-compliance (61.7%), preliminary review (19.8%) and insufficient documentation to permit a substantial full review (18.5%). Disclosure of administrative reasons behind failed applications is a step forward on regulatory transparency, and on internal and external orientation about regulatory mechanisms.O registro de medicamentos contempla a avaliação do cumprimento do caráter administrativo da empresa requerente do registro e o caráter técnico-científico relacionado à eficácia, à segurança e à qualidade do medicamento. Esse trabalho buscou identificar os principais motivos administrativos de indeferimento de registro de medicamentos novos, genéricos e similares no Brasil, além de detalhar o procedimento atual de submissão e instrução de processos de registro. Espera-se que, a partir desta análise, futuros peticionamentos possam ser aprimorados e indeferimentos por tais razões, reduzidos. Para isso, foi realizado levantamento das normas vigentes para o detalhamento do processo de submissão de registro e uma análise retrospectiva dos indeferimentos publicados no Diário Oficial da União através do banco de dados da Agência Nacional de Vigilância Sanitária, Datavisa, do ano de 2015. As principais razões de indeferimento por motivos administrativos foram levantadas nos pareceres de indeferimento e constituem o não cumprimento de prazos (61,7%), a avaliação preliminar de processo (19,8%) e a documentação insuficiente para análise técnica (18,5%). A divulgação de tais razões contribui para a transparência do processo regulatório, orientação interna e externa quanto à aplicabilidade dos atos normativos.Instituto Nacional de Controle de Qualidade em Saúde2017-05-31info: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/83510.22239/2317-269X.00835Health Surveillance under Debate: Society, Science & Technology ; Vol. 5 No. 2 (2017): May; 120-126Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 120-126Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 120-1262317-269Xreponame:Vigilância Sanitária em Debateinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporenghttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/835/379https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/835/519Copyright (c) 2017 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/openAccessdo Carmo, Ana Cerúlia MoraesNogueira, EllenGratieri, Tais2023-06-27T15:19:44Zoai:ojs.visaemdebate.incqs.fiocruz.br:article/835Revistahttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebatePUBhttps://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/oaiincqs.visaemdebate@fiocruz.br || gisele.neves@fiocruz.br2317-269X2317-269Xopendoar:2023-06-27T15:19:44Vigilância Sanitária em Debate - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.none.fl_str_mv Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
Principais razões não técnicas para o indeferimento de registro de medicamentos em 2015
title Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
spellingShingle Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
do Carmo, Ana Cerúlia Moraes
Anvisa
Registro de Medicamento
Medicamento Genérico
Medicamento Similar
Vigilância Sanitária
Anvisa
Products Registration
Generic Drug
Similar Drug
Sanitary Surveillance
title_short Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
title_full Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
title_fullStr Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
title_full_unstemmed Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
title_sort Main non-technical reasons to refuse pharmaceutical drug products registration in 2015
author do Carmo, Ana Cerúlia Moraes
author_facet do Carmo, Ana Cerúlia Moraes
Nogueira, Ellen
Gratieri, Tais
author_role author
author2 Nogueira, Ellen
Gratieri, Tais
author2_role author
author
dc.contributor.author.fl_str_mv do Carmo, Ana Cerúlia Moraes
Nogueira, Ellen
Gratieri, Tais
dc.subject.por.fl_str_mv Anvisa
Registro de Medicamento
Medicamento Genérico
Medicamento Similar
Vigilância Sanitária
Anvisa
Products Registration
Generic Drug
Similar Drug
Sanitary Surveillance
topic Anvisa
Registro de Medicamento
Medicamento Genérico
Medicamento Similar
Vigilância Sanitária
Anvisa
Products Registration
Generic Drug
Similar Drug
Sanitary Surveillance
description The registration of pharmaceutical drug products involves reviewing company’s administrative aspects as well as technical-scientific aspects related to efficacy, safety and quality. This study evaluated the main administrative reasons for registration refusals of new, generic and similar (branded generic) pharmaceutical drug products in Brazil. Actual submission procedure and process instruction is presented in detail. The aim is to contribute for the improvement of novel applications, reducing non-technical refusals. A retrospective search of registration refusals in 2015 published by the Brazilian Government Official Gazette using Anvisa database, called Datavisa, was performed. The main reasons for non-technical registration refusals of generic and similar pharmaceutical drug products were deadline non-compliance (61.7%), preliminary review (19.8%) and insufficient documentation to permit a substantial full review (18.5%). Disclosure of administrative reasons behind failed applications is a step forward on regulatory transparency, and on internal and external orientation about regulatory mechanisms.
publishDate 2017
dc.date.none.fl_str_mv 2017-05-31
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/835
10.22239/2317-269X.00835
url https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/835
identifier_str_mv 10.22239/2317-269X.00835
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/835/379
https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/835/519
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. 5 No. 2 (2017): May; 120-126
Vigilancia en Salud en Debate: Sociedad, Ciencia y Tecnología; Vol. 5 Núm. 2 (2017): Puede; 120-126
Vigil Sanit Debate, Rio de Janeiro; v. 5 n. 2 (2017): Maio; 120-126
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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