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...
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Universidad de Antioquia
2009
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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) |
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orphan drugs exceptional drugs rare disease neglected disease legislation Food processing and manufacture TP368-456 Pharmaceutical industry HD9665-9675 |
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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 |
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_version_ |
1718420422056214528 |