EMA Defines Actions For Using CAR-T Registries For Regulatory Evaluation
A multi-stakeholder EU workshop has helped identify how patient registries can support the benefit-risk evaluation of CAR-T cell therapies, given the challenges posed by these products, not least the need for the long-term follow up of treated patients.
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CAR T-cell therapies have resulted in the industry and regulators exploring unconventional approaches to collecting real-world safety and efficacy data from existing registries. Can this approach also work for other types of cell and gene therapy products in the future? Delegates at a conference in London explored the topic.
With just three marketing applications filed, the European Medicines Agency says it is too soon to say whether PRIME, its priority medicines scheme, is meeting its objective. The agency is satisfied, though, that the scheme has started to drive innovation.
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.