18 July 2019 - Although patient registries can be heterogenous in their quality and design, a new study in Drug Safety co-authored by a EMA official explains how patient registries could provide valuable data for regulatory decisions.

The authors explain how such registries can be used when randomised controlled trials are not feasible, such as with some rare diseases, or to meet post-marketing commitments.

“For products granted conditional marketing approval, registry studies may provide post-authorisation data to fulfil regulator-imposed specific obligations to confirm safety and/or effectiveness, as is the case with the recently authorised chimeric antigen receptor (CAR) T-cell products, tiagenlecleucel and axicabtagene ciloleucel,” the study says.

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