Module 9 2021

Take away messages

Evolving regulatory landscape ATMP regulation ● Fine tuning of ATMP and hospital exemption to avoid disparity ● Streamlined processes and refined requirement for ATMP MA authorization • Adaptive Marketing Authorization • Flexibility of the CTD format • Tailoring the requirement of the specific products (allogeneic vs autologous) ● Extension certification procedures to non-clinical data and other potential developers ● Incentive extention to post-market phase Definition of the starting materials, raw materials, DS and DP Comparability criteria Environmental Risk assessment

Novartis Pharma AG- Business use only- not for further distribution

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