Document Detail


Advanced Therapy Medicinal Products and Exemptions to the Regulation 1394/2007: How Confident Can We be? An Exploratory Analysis.
MedLine Citation:
PMID:  22347860     Owner:  NLM     Status:  PubMed-not-MEDLINE    
Abstract/OtherAbstract:
The market authorization procedure for medicinal products for human use is relying on their demonstrated efficacy, safety, and pharmaceutical quality. This applies to all medicinal products whether of chemical or biological origin. Since October 2009, the first advanced therapy medicinal product (ATMP) has been authorized through the centralized procedure. ATMPs are gene therapy medicinal products, somatic cell therapy medicinal products or tissue-engineered products. An appropriate ATMP - Regulation is dealing with ATMP requirements. Two exemptions are foreseen to the ATMP Regulation: (a) Products, which were legally on the Community market when the Regulation became applicable, should comply to the Regulation by December 30, 2012. (b) The hospital exemption rule for non-routine products for an individual patient. In this work we explored whether the actual application of the Regulation on ATMPs is in line with the aim of the Regulation in terms of guaranteeing the highest level of health protection for patients. Based on the analysis of the relative efficacy of the only EC authorized ATMP and its exempted alternatives, there is evidence against this Regulation 1394/2007 assumption.
Authors:
Philippe Van Wilder
Publication Detail:
Type:  Journal Article     Date:  2012-02-14
Journal Detail:
Title:  Frontiers in pharmacology     Volume:  3     ISSN:  1663-9812     ISO Abbreviation:  Front Pharmacol     Publication Date:  2012  
Date Detail:
Created Date:  2012-02-20     Completed Date:  2012-10-02     Revised Date:  2013-08-13    
Medline Journal Info:
Nlm Unique ID:  101548923     Medline TA:  Front Pharmacol     Country:  Switzerland    
Other Details:
Languages:  eng     Pagination:  12     Citation Subset:  -    
Affiliation:
TiGenix NV Leuven, Belgium.
Export Citation:
APA/MLA Format     Download EndNote     Download BibTex
MeSH Terms
Descriptor/Qualifier:

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


Previous Document:  CyPPA, a Positive SK3/SK2 Modulator, Reduces Activity of Dopaminergic Neurons, Inhibits Dopamine Rel...
Next Document:  Bilirubin, renal hemodynamics, and blood pressure.