EMA To Establish Minimum Requirements For CAR-T Cell Registries

The European Medicines Agency is exploring the possibility of establishing minimum requirements for all CAR-T Cell registries in the EU to facilitate efficient data collection on such products in the post-authorization phase.

CAR T-cell therapy
EMA Initiative Seeks To Align CAR-T Cell Registries • Source: Shutterstock

The European Medicines Agency is working on an initiative to establish a common protocol, or a minimum set of requirements, for registries for CAR-T cells that are regulated as advanced therapy medicinal products (ATMPs) in the EU.

The initiative will include the EMA hosting a registries workshop that will result in a report "summarising the discussions of...

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