Loading...
Clinical development of gene therapy needs a tailored approach: a regulatory perspective from the European Union.
Narayanan, Gopalan Cossu, Giulio Galli, Maria Cristina Flory, Egbert Ovelgonne, Hans Salmikangas, Paula Schneider, Christian K Trouvin, Jean-Hugues
Narayanan, Gopalan
Cossu, Giulio
Galli, Maria Cristina
Flory, Egbert
Ovelgonne, Hans
Salmikangas, Paula
Schneider, Christian K
Trouvin, Jean-Hugues
Citations
Altmetric:
Advisors
Editors
Other Contributors
Issue Date
2014-03
Submitted date
Files
Loading...
allowed publisher's PDF
Adobe PDF, 246.89 KB
Other Titles
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
Affiliation
Publisher
PubMed ID
PubMed Central ID
Additional Links
Embedded video
Type
Article
Language
en
Description
Series/Report no.
ISSN
2324-8645
EISSN
ISBN
ISMN
Gov't Doc #
Sponsors
License
Archived with thanks to Human gene therapy. Clinical development