Medicinal Product Regulation: Portugal׳s Framework
Autor(a) principal: | |
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Data de Publicação: | 2016 |
Outros Autores: | , , |
Tipo de documento: | Artigo |
Idioma: | eng |
Título da fonte: | Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
Texto Completo: | http://hdl.handle.net/10314/6664 https://doi.org/10.1016/j.clinthera.2016.07.171 |
Resumo: | Purpose: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). Methods: From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. Findings: In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. Implications: The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. |
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Medicinal Product Regulation: Portugal׳s FrameworkNational Regulatory AgencyPortugalmarketing authorizationmedicinal products regulationPurpose: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). Methods: From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. Findings: In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. Implications: The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances.2023-01-20T12:18:00Z2023-01-202016-08-27T00:00:00Zinfo:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articlehttp://hdl.handle.net/10314/6664http://hdl.handle.net/10314/6664https://doi.org/10.1016/j.clinthera.2016.07.171eng27574988Herdeiro, Maria TBastos, Paulo DRodrigues, António TRoque, Fátimainfo:eu-repo/semantics/openAccessreponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos)instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãoinstacron:RCAAP2024-01-14T02:59:56Zoai:bdigital.ipg.pt:10314/6664Portal AgregadorONGhttps://www.rcaap.pt/oai/openaireopendoar:71602024-03-20T01:44:12.914606Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informaçãofalse |
dc.title.none.fl_str_mv |
Medicinal Product Regulation: Portugal׳s Framework |
title |
Medicinal Product Regulation: Portugal׳s Framework |
spellingShingle |
Medicinal Product Regulation: Portugal׳s Framework Herdeiro, Maria T National Regulatory Agency Portugal marketing authorization medicinal products regulation |
title_short |
Medicinal Product Regulation: Portugal׳s Framework |
title_full |
Medicinal Product Regulation: Portugal׳s Framework |
title_fullStr |
Medicinal Product Regulation: Portugal׳s Framework |
title_full_unstemmed |
Medicinal Product Regulation: Portugal׳s Framework |
title_sort |
Medicinal Product Regulation: Portugal׳s Framework |
author |
Herdeiro, Maria T |
author_facet |
Herdeiro, Maria T Bastos, Paulo D Rodrigues, António T Roque, Fátima |
author_role |
author |
author2 |
Bastos, Paulo D Rodrigues, António T Roque, Fátima |
author2_role |
author author author |
dc.contributor.author.fl_str_mv |
Herdeiro, Maria T Bastos, Paulo D Rodrigues, António T Roque, Fátima |
dc.subject.por.fl_str_mv |
National Regulatory Agency Portugal marketing authorization medicinal products regulation |
topic |
National Regulatory Agency Portugal marketing authorization medicinal products regulation |
description |
Purpose: The pharmaceutical industry is one of the most tightly regulated sectors, and it is essential to know each country׳s legal framework to understand the regulation, approval, and marketing of medicinal products for human use. This article describes the main statutes and procedures governing medicinal products for human use in Portugal and the role of the country׳s National Medicines and Health Products Authority (Autoridade Nacional do Medicamento e Produtos de Saúde, I.P.; INFARMED). Methods: From the most recently available data, an update of requests and approvals concerning marketing authorizations, variations, pricing, and reimbursements is provided. Data were sourced from the INFARMED website, Infomed (database of medicinal products for human use), and periodic reports issued by national authorities. Organic laws, acts, and law decrees published in the government gazette (Diário da República) are cited and reproduced as required. Findings: In 2015 Portugal ranked fifth in the European System of Medicines Evaluation in terms of the number of completed procedures as a reference member state. Approximately 80% of all approved drug applications in Portugal in 2015 were for generic drugs, mostly pertaining to the nervous system. In Portugal, INFARMED monitors drug quality, safety profile, and efficacy in all stages of the drug life cycle, ensuring patients' safety. Implications: The Portuguese market for medicinal products for human use has been appreciably changed by the advent of generic drugs. There is an increased trend for new request applications for biological and biotechnological substances. |
publishDate |
2016 |
dc.date.none.fl_str_mv |
2016-08-27T00:00:00Z 2023-01-20T12:18:00Z 2023-01-20 |
dc.type.status.fl_str_mv |
info:eu-repo/semantics/publishedVersion |
dc.type.driver.fl_str_mv |
info:eu-repo/semantics/article |
format |
article |
status_str |
publishedVersion |
dc.identifier.uri.fl_str_mv |
http://hdl.handle.net/10314/6664 http://hdl.handle.net/10314/6664 https://doi.org/10.1016/j.clinthera.2016.07.171 |
url |
http://hdl.handle.net/10314/6664 https://doi.org/10.1016/j.clinthera.2016.07.171 |
dc.language.iso.fl_str_mv |
eng |
language |
eng |
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27574988 |
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info:eu-repo/semantics/openAccess |
eu_rights_str_mv |
openAccess |
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reponame:Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) instname:Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação instacron:RCAAP |
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Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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RCAAP |
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RCAAP |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) |
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Repositório Científico de Acesso Aberto de Portugal (Repositórios Cientìficos) - Agência para a Sociedade do Conhecimento (UMIC) - FCT - Sociedade da Informação |
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