EMA ATMP Recommendations

[membership level=”0,4″][The content continues for paid members only.] Login or Subscribe [/membership][membership level=”1,5,6,7,8,9,10,11,12″][membership] 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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