As a result of extensive interaction with the EMA that started in late 2016 when the EBMT responded to the EMA’s Patient Registry Initiative, the EBMT registry has been qualified as a suitable platform for the collection of data for post-authorisation safety surveillance (PASS) and efficacy studies. The registry is now considered suitable to perform pharmacoepidemiological studies for regulatory purposes, concerning Chimeric Antigen Receptor (CAR) T-cell therapy used in the treatment of haematological malignancies.
Jürgen Kuball, EBMT treasurer and liaison with the EMA, says: “The EBMT is proud that EMA formally recognises the value of our registry. This recognition will lead to an improved communication across the various stakeholders, including registry owners, regulators and marketing authorisation holders, giving confidence to users on the data collected and ultimately bring safe and effective therapies to our patients”.
Read the full press release here