Clinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union.

2.50
Hdl Handle:
http://hdl.handle.net/10033/332723
Title:
Clinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union.
Authors:
Narayanan, Gopalan; Cossu, Giulio; Galli, Maria Cristina; Flory, Egbert; Ovelgonne, Hans; Salmikangas, Paula; Schneider, Christian K; Trouvin, Jean-Hugues
Abstract:
Gene therapy is a rapidly evolving field that needs an integrated approach, as acknowledged in the concept article on the revision of the guideline on gene transfer medicinal products. The first gene therapy application for marketing authorization was approved in the International Conference on Harmonisation (ICH) region in 2012, the product being Alipogene tiparvovec. The regulatory process for this product has been commented on extensively, highlighting the challenges posed by such a novel technology. Here, as current or previous members of the Committee for Advanced Therapies, we share our perspectives and views on gene therapy as a treatment modality based on current common understanding and regulatory experience of gene therapy products in the European Union to date. It is our view that a tailored approach is needed for a given gene therapy product in order to achieve successful marketing authorization.
Citation:
Clinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union. 2014, 25 (1):1-6 Hum Gene Ther Clin Dev
Journal:
Human gene therapy. Clinical development
Issue Date:
Mar-2014
URI:
http://hdl.handle.net/10033/332723
DOI:
10.1089/humc.2013.230
PubMed ID:
24649836
Type:
Article
Language:
en
ISSN:
2324-8645
Appears in Collections:
publications of the department of experimental infection research ([TC] EXPI)

Full metadata record

DC FieldValue Language
dc.contributor.authorNarayanan, Gopalanen
dc.contributor.authorCossu, Giulioen
dc.contributor.authorGalli, Maria Cristinaen
dc.contributor.authorFlory, Egberten
dc.contributor.authorOvelgonne, Hansen
dc.contributor.authorSalmikangas, Paulaen
dc.contributor.authorSchneider, Christian Ken
dc.contributor.authorTrouvin, Jean-Huguesen
dc.date.accessioned2014-10-13T08:49:00Z-
dc.date.available2014-10-13T08:49:00Z-
dc.date.issued2014-03-
dc.identifier.citationClinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union. 2014, 25 (1):1-6 Hum Gene Ther Clin Deven
dc.identifier.issn2324-8645-
dc.identifier.pmid24649836-
dc.identifier.doi10.1089/humc.2013.230-
dc.identifier.urihttp://hdl.handle.net/10033/332723-
dc.description.abstractGene therapy is a rapidly evolving field that needs an integrated approach, as acknowledged in the concept article on the revision of the guideline on gene transfer medicinal products. The first gene therapy application for marketing authorization was approved in the International Conference on Harmonisation (ICH) region in 2012, the product being Alipogene tiparvovec. The regulatory process for this product has been commented on extensively, highlighting the challenges posed by such a novel technology. Here, as current or previous members of the Committee for Advanced Therapies, we share our perspectives and views on gene therapy as a treatment modality based on current common understanding and regulatory experience of gene therapy products in the European Union to date. It is our view that a tailored approach is needed for a given gene therapy product in order to achieve successful marketing authorization.en
dc.language.isoenen
dc.rightsArchived with thanks to Human gene therapy. Clinical developmenten
dc.titleClinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union.en
dc.typeArticleen
dc.identifier.journalHuman gene therapy. Clinical developmenten

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