Questions and answers on gene therapy

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Questions and answers

Reference numberCHMP/GTWP/212377/08
Published12/01/2010
KeywordsGene therapy medicinal products, European Pharmacopoeia, comparability, characterisation, host cell DNA, selection marker, potency, viral shedding, GMO requirements
DescriptionThis document addresses questions on matters related to the development of gene therapy medicinal products. It provides harmonized position on issues that can be subject to different interpretation or require clarification, typically arising from discussions during briefing meetings with stakeholders.


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