VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST

A comparative revision was carried out on the national and international policies and regulations about access of orphan and/or vital drugs.. An analysis of: orphan drugs´ list from USA, European Union and all applications for importation of not available drugs submitted by the Drug Regulatory Autho...

Descripción completa

Guardado en:
Detalles Bibliográficos
Autores principales: Gloria A. SANDOVAL, Claudia P. VACCA G, Jorge OLARTE
Formato: article
Lenguaje:EN
Publicado: Universidad de Antioquia 2009
Materias:
Acceso en línea:https://doaj.org/article/3a565dfc710f46d5a42c3ae53e1fd181
Etiquetas: Agregar Etiqueta
Sin Etiquetas, Sea el primero en etiquetar este registro!
id oai:doaj.org-article:3a565dfc710f46d5a42c3ae53e1fd181
record_format dspace
spelling oai:doaj.org-article:3a565dfc710f46d5a42c3ae53e1fd1812021-11-19T04:18:48ZVITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST0121-40042145-2660https://doaj.org/article/3a565dfc710f46d5a42c3ae53e1fd1812009-02-01T00:00:00Zhttps://revistas.udea.edu.co/index.php/vitae/article/view/769https://doaj.org/toc/0121-4004https://doaj.org/toc/2145-2660A comparative revision was carried out on the national and international policies and regulations about access of orphan and/or vital drugs.. An analysis of: orphan drugs´ list from USA, European Union and all applications for importation of not available drugs submitted by the Drug Regulatory Authority (INVIMA) until 2006; an informal consultation with health care providers, insurance companies and distributors of vital medicines, were included, in order to improve the actual vital drugs list within the frame of public health programs. The analysis included all drugs that have been protected by Decree 2085 from 2002, as well as the imported drugs by the Ministry of Social Welfare under the public health program. 26 of 107 proposed drugs match the lists of orphan drugs from the countries analyzed and 12 are protected with exclusivity by decree 2085 from 2002. Gloria A. SANDOVALClaudia P. VACCA GJorge OLARTEUniversidad de Antioquiaarticleorphan drugsexceptional drugsrare diseaseneglected diseaselegislationFood processing and manufactureTP368-456Pharmaceutical industryHD9665-9675ENVitae, Vol 15, Iss 1 (2009)
institution DOAJ
collection DOAJ
language EN
topic orphan drugs
exceptional drugs
rare disease
neglected disease
legislation
Food processing and manufacture
TP368-456
Pharmaceutical industry
HD9665-9675
spellingShingle orphan drugs
exceptional drugs
rare disease
neglected disease
legislation
Food processing and manufacture
TP368-456
Pharmaceutical industry
HD9665-9675
Gloria A. SANDOVAL
Claudia P. VACCA G
Jorge OLARTE
VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
description A comparative revision was carried out on the national and international policies and regulations about access of orphan and/or vital drugs.. An analysis of: orphan drugs´ list from USA, European Union and all applications for importation of not available drugs submitted by the Drug Regulatory Authority (INVIMA) until 2006; an informal consultation with health care providers, insurance companies and distributors of vital medicines, were included, in order to improve the actual vital drugs list within the frame of public health programs. The analysis included all drugs that have been protected by Decree 2085 from 2002, as well as the imported drugs by the Ministry of Social Welfare under the public health program. 26 of 107 proposed drugs match the lists of orphan drugs from the countries analyzed and 12 are protected with exclusivity by decree 2085 from 2002.
format article
author Gloria A. SANDOVAL
Claudia P. VACCA G
Jorge OLARTE
author_facet Gloria A. SANDOVAL
Claudia P. VACCA G
Jorge OLARTE
author_sort Gloria A. SANDOVAL
title VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
title_short VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
title_full VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
title_fullStr VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
title_full_unstemmed VITAL MEDICINES NOT AVAILABLE: NATIONAL AND INTERNATIONAL REGULATION ANALYSIS, UPDATE PROPOSAL OF NATIONAL LIST
title_sort vital medicines not available: national and international regulation analysis, update proposal of national list
publisher Universidad de Antioquia
publishDate 2009
url https://doaj.org/article/3a565dfc710f46d5a42c3ae53e1fd181
work_keys_str_mv AT gloriaasandoval vitalmedicinesnotavailablenationalandinternationalregulationanalysisupdateproposalofnationallist
AT claudiapvaccag vitalmedicinesnotavailablenationalandinternationalregulationanalysisupdateproposalofnationallist
AT jorgeolarte vitalmedicinesnotavailablenationalandinternationalregulationanalysisupdateproposalofnationallist
_version_ 1718420422056214528