Module 9 2021

ATMPs regulation showed pitfalls that call for revision

Assessment and registration ● CTD structure unsuitable ● Step-wise authorizations mechanism ● Further guidance on quality data filing requirement

● Training and education platform in MAA for SME and academia ● Notified body interaction for combined ATMP assessment procedure

Incentives ● Extension of the certification procedure (to non-clinical data)

● Extension of incentives package to academia, trust and small research groups ● Extension of the certification procedure Academia an no-profit organization ● Post-marketing incentives

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