Record Details

European and Italian regulation on orphan medicinal products

Farmeconomia

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Field Value
 
Title European and Italian regulation on orphan medicinal products
 
Creator Joppi, Roberta
 
Subject —
Orphan drugs; Rare diseases; Pharmaceutical legislation
 
Description The paper presents an overview of the European and Italian Regulation on Orphan Medicinal Products (OMPs), along with some data on the OMPs licensed in the EU from 2000 to 2012. The EU legislation encourages pharmaceutical companies to develop drugs for rare diseases, so-called “orphan drugs”. The European Medicine Agency recognizes orphan drug status mainly on the basis of the prevalence of the disease (≤ 5/10,000), and potential benefit. Orphan status implies incentives for pharmaceutical companies. From 2000 up to 2012 890 candidate orphan drug designations received a positive opinion and the marketing authorization was granted to 72 OMPs corresponding to 80 different indications. Currently, 59 OMPs are available to Italian patients either because licensed to the market by the AIFA or included in the list of the L. 648/96. Despite of an encouraging regulation nearly all the currently estimated rare diseases still await treatments.
 
Publisher SEEd
 
Contributor —
 
Date 2013-03-22
 
Type info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
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Format text/html
application/pdf
 
Identifier http://journals.edizioniseed.it/index.php/FE/article/view/633
10.7175/fe.v14i2.633
 
Source Farmeconomia. Health economics and therapeutic pathways; Vol 14, No 2 (2013); 89-98
2240-256X
1721-6915
 
Language eng
 
Relation http://journals.edizioniseed.it/index.php/FE/article/view/633/775
http://journals.edizioniseed.it/index.php/FE/article/view/633/776
http://journals.edizioniseed.it/index.php/FE/article/downloadSuppFile/633/55
http://journals.edizioniseed.it/index.php/FE/article/downloadSuppFile/633/56
http://journals.edizioniseed.it/index.php/FE/article/downloadSuppFile/633/57
 
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