Module 9 2021

ATMPs regulation showed pitfalls that call for revision

Flexibility of data package ● Autologous vs allogeneic ● Frozen vs fresh material ● Quality of reagents and starting materials ● DS definition

Lack of harmonized application ● Transitional period

● CAT / CHMP different assessment criteria ● Divergent opinion on ATMP classification ● Hospital exemption – Too vague definition of routine / non routine use – Tool for circumventing obligation for MA or for pushing forward development of products?

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