Design modifications of gene therapy medicinal products during development

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Reflection paper

Reference numberCAT/GTWP/44236/2009
Published09/02/2012
KeywordsGene therapy, modifications to product design
DescriptionThis document presents regulatory considerations given for specific gene therapy medicinal products where the characteristics have been changed at various stages during clinical development. It gives some insight into the types of studies that are likely to be required in an application dossier to support the modification in the product design introduced during development.


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