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In late August, EMA posted recommendations on the classification of various types of advanced-therapy medicinal products (ATMPs) as a somatic cell therapy, tissue-engineered treatment, or a gene therapy, which includes a rationale for the recommen-dation. In addition, the agency clarified that in vitro-derived platelets fall outside of the scope of the ATMP classifications because they lack a nucleus, and as such are not considered cells.
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