EBMT NEWSLETTER | July 2018 | Volume 61 - Issue 2

European Medicines Agency and EBMT Registry

The EBMT continues to have fruitful interactions with the EU and its institutions. The most significant achievement recently was the publication for consultation on 29 June of the European Medicines Agency qualification opinion on the EBMT registry for follow-up of CAR-T cell therapy recipients. This is of major significance representing an endorsement of the governance, structures, reach and quality of the registry and will put EBMT firmly in the centre of rolling out these novel therapies. It also represents the reward for all the hard work invested since last October in preparing the EMA process by EBMT staff and expert volunteers.

The opinion has also raised the profile of the registry among industry who are showing high interest in collaborating with EBMT on studies in the area of cellular therapy.

More information can be found at https://www.ebmt.org/

Health Technology Assessment

EBMT was also represented at the EU Health Technology Assessment stakeholders’ conference held on 9 July 2018. Over 300 participants from industry, national agencies, patient groups and healthcare professionals participated.

HTA is the process whereby medicinal products, devices or treatments are assessed for value and pricing. In an age when new therapies are showing enormous promise but at high cost, HTA is the key process affecting access to care for patients. Healthcare professionals have a role to play in this process and are encouraged to engage with EU initiatives such as EunetHTA which is attempting to coordinate better the HTA processes across the EU member states.

As with EMA, data is the key to EBMT’s role and it is becoming clear that the registry is a resource for stakeholders beyond the strictly scientific and medical community.
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