Draft reflection paper on classification of advanced-therapy medicinal products

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Download document Draft reflection paper on classification of advanced-therapy medicinal products
Reference number EMA/CAT/600280/2010 Rev.1
Status draft: consultation open
First published 30/06/2014
Last updated 30/06/2014
Consultation start date 30/06/2014
Consultation end date 31/10/2014
Email address for submissions advancedtherapies@ema.europa.eu

Summary

This reflection paper has been updated to reflect the current thinking of the Committee on Advanced Therapies (CAT) on substantial manipulation and non-homologous use. Additional changes have been implemented throughout the text to clarify the existing concepts, e.g. the demarcation between vaccines against infectious diseases and gene-therapy medicinal products and the criteria for combined advanced-therapy medicinal products.