Module 18 2021

Care needed in definition

● Cells/tissue and device must be integral ● Non-cellular component must meet device definition on its own ● Cell/tissue component must provide primary MOA – Default if cells are viable (Article 2.2) – If cells are non-viable, scientific evidence of primary contribution to MOA ● ATMP component may be TEP, SCT or GT ● Reflection paper on classification of advanced therapy medicinal products (EMA/CAT/600280/2010 rev.1)

– Discusses distinction between the four classifications of ATMP – In cases where still unclear, use classification procedure – EMA 60 day process – Committee on Advanced Therapies (CAT) recommendation

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TOPRA MSc Module 18: Drug Device Combinations and other Technology