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EBMT and the EU Joint Action on Health Technology Assessment

by Eoin McGrath
EBMT Organization
Legal & Regulatory Affairs Committee

Following the positive qualification opinion issued by EMA on the EBMT registry module for cellular therapies in February 2019, EBMT engaged in a similar process with EUnetHTA, the EU Joint Action on Health Technology Assessment (HTA). The process aimed to establish whether the EBMT registry is suitable to support Post Launch Evidence Generation (PLEG) for HTA purposes in the area of cellular therapies. Learn more about the EUnetHTA PLEG Activities

Run as a pilot project, participating HTA bodies identified a minimum data set for HTA purposes that was shared with EBMT using their novel Registry Evaluation and Quality Standards Tool (REQueST) tool. Whilst the COVID pandemic unfortunately caused significant delays to EUnetHTA's activities during 2020 and the process was not concluded until mid-2021, nonetheless, the overall findings were positive with considerable overlap between the two data sets. Read the summary of HTA recommendations

Similar to the EMA qualification process, our engagement with EUnetHTA completely aligned with EBMT's efforts to develop and improve our registry. By opening our processes and structures to external scrutiny, we are learning where our strengths lie and where we have areas for improvement. EBMT warmly welcomes the collaboration with this new (for EBMT) group of stakeholders further strengthening our mission to minimise duplication of data collection and take a step closer to the goal of 'collect once and use often'.