|Download document||Draft reflection paper on classification of advanced-therapy medicinal products|
|Reference number||EMA/CAT/600280/2010 Rev.1|
|Status||draft: consultation closed|
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.