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EMA: Draft reflection paper on classification of advanced-therapy medicinal products

07.08.2014
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.