Document Detail


Regulatory considerations in production of a cell therapy medicinal product in Europe to clinical research.
MedLine Citation:
PMID:  23014774     Owner:  NLM     Status:  Publisher    
Abstract/OtherAbstract:
The development of new drugs using stem cells has become a clinic alternative for the treatment of different diseases such as Alzheimer's, diabetes and myocardial infarction. Similar to conventional medicines, stem cells as new medicinal products for cell therapy are subjected to current legislation concerning their manufacture process. Besides, their legality is determined by the Regulatory Agencies belonging to the Member State of the European Union in which they are being registered. With the evolution of therapy that uses cells as medicines, there is a need to develop the appropriate legislative and regulatory framework capable of ensuring their safety and effectiveness. However, few works have been published regarding the regulations that these products must comply through production and commercialization processes. The present work is focused on the description of key events during clinical development and cell production of stem cells as drugs. Such as the regulations, requirements and directives involved in the production of cell therapy medicinal products, from the clinical design stage to its commercialization in Europe.
Authors:
Patricia Gálvez Martín; Adolfina Ruiz Martinez; Visitación Gallardo Lara; Beatriz Clares Naveros
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Publication Detail:
Type:  JOURNAL ARTICLE     Date:  2012-9-27
Journal Detail:
Title:  Clinical and experimental medicine     Volume:  -     ISSN:  1591-9528     ISO Abbreviation:  Clin. Exp. Med.     Publication Date:  2012 Sep 
Date Detail:
Created Date:  2012-9-27     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  100973405     Medline TA:  Clin Exp Med     Country:  -    
Other Details:
Languages:  ENG     Pagination:  -     Citation Subset:  -    
Affiliation:
Cellular Production Unit, Andalusian Molecular Biology and Regenerative Medicine Centre (CABIMER), Americo Vespucio Avenue s/n, 41092, Seville, Spain, patricia.galvez@cabimer.es.
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