Comments on the Phytomedicines Register
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2006 |
| Outros Autores: | , , |
| Tipo de documento: | Artigo |
| Idioma: | por |
| Título da fonte: | Revista Fitos |
| Texto Completo: | https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30 |
Resumo: | Phytomedicines are the drugs obtained using exclusively vegetal drug derivates as active constituents, characterized by the knowledge of the effectiveness and the risks of its use, as well as for its quality constancy. Effectiveness and safety can be validated through ethnopharmacological surveys, scientific publications or pre-clinic and clinic pharmacological studies. Safety can also be determined by assays that prove the identity of the plant and the absence of contaminants. The quality must be reached through a control of the raw materials, pharmaceutical formulation, packing materials and stability studies. This article describes some topics of the phytomedicine registration process in the National Health Surveillance Agency (ANVISA), Brazilian agency that regulates and register medicines. |
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Comments on the Phytomedicines RegisterComentários sobre o Registro de FitoterápicosPhytomedicinedrugpublic healthANVISAregisterregulationFitoterápicosmedicamentossaúde públicaANVISAregistroregulaçãoPhytomedicines are the drugs obtained using exclusively vegetal drug derivates as active constituents, characterized by the knowledge of the effectiveness and the risks of its use, as well as for its quality constancy. Effectiveness and safety can be validated through ethnopharmacological surveys, scientific publications or pre-clinic and clinic pharmacological studies. Safety can also be determined by assays that prove the identity of the plant and the absence of contaminants. The quality must be reached through a control of the raw materials, pharmaceutical formulation, packing materials and stability studies. This article describes some topics of the phytomedicine registration process in the National Health Surveillance Agency (ANVISA), Brazilian agency that regulates and register medicines.Fitoterápico é o medicamento obtido empregando-se exclusivamente derivados de droga vegetal como constituintes ativos, caracterizado pelo conhecimento da eficácia e dos riscos de seu uso, assim como pela constância de sua qualidade. A eficácia e segurança podem ser validadas através de levantamentos etnofarmacológicos de utilização, publicações tecnocientíficas ou estudos farmacológicos e toxicológicos pré-clínicos e clínicos. A segurança também é determinada pelos ensaios que comprovam a identidade da planta e a ausência de contaminantes. A qualidade deve ser alcançada mediante o controle das matérias-primas, do produto acabado, materiais de embalagem, formulação farmacêutica e estudos de estabilidade. Este artigo descreve alguns tópicos do registro de fitoterápicos junto à Agência Nacional de Vigilância Sanitária (ANVISA), órgão brasileiro que regula e registra medicamentos. Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz2006-03-31info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdftext/htmlhttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/3010.32712/2446-4775.2006.30Revista Fitos; Vol. 1 No. 03 (2006); 9-17Revista Fitos; Vol. 1 Núm. 03 (2006); 9-17Revista Fitos; v. 1 n. 03 (2006); 9-172446-47751808-9569reponame:Revista Fitosinstname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZporhttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30/pdf_22https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30/1318Copyright (c) 2006 Revista Fitos Eletrônicahttps://creativecommons.org/licenses/by/4.0info:eu-repo/semantics/openAccessNetto, E.M.Shuqair, N.S.M.S.A.Q.Balbino, E.E.Carvalho, A.C.B.2022-11-09T18:58:48Zoai:ojs.revistafitos.far.fiocruz.br:article/30Revistahttps://revistafitos.far.fiocruz.br/index.php/revista-fitos/PUBhttp://revistafitos.far.fiocruz.br/index.php/revista-fitos/oairevistafitos@far.fiocruz.br || eugenio.telles@far.fiocruz.br2446-47752446-4775opendoar:2022-11-09T18:58:48Revista Fitos - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.none.fl_str_mv |
Comments on the Phytomedicines Register Comentários sobre o Registro de Fitoterápicos |
| title |
Comments on the Phytomedicines Register |
| spellingShingle |
Comments on the Phytomedicines Register Netto, E.M. Phytomedicine drug public health ANVISA register regulation Fitoterápicos medicamentos saúde pública ANVISA registro regulação |
| title_short |
Comments on the Phytomedicines Register |
| title_full |
Comments on the Phytomedicines Register |
| title_fullStr |
Comments on the Phytomedicines Register |
| title_full_unstemmed |
Comments on the Phytomedicines Register |
| title_sort |
Comments on the Phytomedicines Register |
| author |
Netto, E.M. |
| author_facet |
Netto, E.M. Shuqair, N.S.M.S.A.Q. Balbino, E.E. Carvalho, A.C.B. |
| author_role |
author |
| author2 |
Shuqair, N.S.M.S.A.Q. Balbino, E.E. Carvalho, A.C.B. |
| author2_role |
author author author |
| dc.contributor.author.fl_str_mv |
Netto, E.M. Shuqair, N.S.M.S.A.Q. Balbino, E.E. Carvalho, A.C.B. |
| dc.subject.por.fl_str_mv |
Phytomedicine drug public health ANVISA register regulation Fitoterápicos medicamentos saúde pública ANVISA registro regulação |
| topic |
Phytomedicine drug public health ANVISA register regulation Fitoterápicos medicamentos saúde pública ANVISA registro regulação |
| description |
Phytomedicines are the drugs obtained using exclusively vegetal drug derivates as active constituents, characterized by the knowledge of the effectiveness and the risks of its use, as well as for its quality constancy. Effectiveness and safety can be validated through ethnopharmacological surveys, scientific publications or pre-clinic and clinic pharmacological studies. Safety can also be determined by assays that prove the identity of the plant and the absence of contaminants. The quality must be reached through a control of the raw materials, pharmaceutical formulation, packing materials and stability studies. This article describes some topics of the phytomedicine registration process in the National Health Surveillance Agency (ANVISA), Brazilian agency that regulates and register medicines. |
| publishDate |
2006 |
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2006-03-31 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30 10.32712/2446-4775.2006.30 |
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https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30 |
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10.32712/2446-4775.2006.30 |
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por |
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por |
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https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30/pdf_22 https://revistafitos.far.fiocruz.br/index.php/revista-fitos/article/view/30/1318 |
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Copyright (c) 2006 Revista Fitos Eletrônica https://creativecommons.org/licenses/by/4.0 info:eu-repo/semantics/openAccess |
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Copyright (c) 2006 Revista Fitos Eletrônica https://creativecommons.org/licenses/by/4.0 |
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openAccess |
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application/pdf text/html |
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Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz |
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Centro de Inovação em Biodiversidade e Saúde - Farmanguinhos/Fiocruz |
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Revista Fitos; Vol. 1 No. 03 (2006); 9-17 Revista Fitos; Vol. 1 Núm. 03 (2006); 9-17 Revista Fitos; v. 1 n. 03 (2006); 9-17 2446-4775 1808-9569 reponame:Revista Fitos instname:Fundação Oswaldo Cruz (FIOCRUZ) instacron:FIOCRUZ |
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revistafitos@far.fiocruz.br || eugenio.telles@far.fiocruz.br |
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