In late June, EMA released a revised version of its “Reflection paper on classification of advanced therapy medicinal products.” The revision provides further clarification on when medicines may be classified as ATMPs and when they cannot. Clarification is added on: ● what constitutes a substantial manipulation of cells or tissues ● what is considered a non-homologous use of cells or tissues ● when medicines based on recombinant viral vectors are considered as vaccines, as opposed to gene-therapy products, and ● the criteria for classification of combined ATMPs, i.e. products that incorporate an active substance and one or more medical devices.
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