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EBMT responds to the publication of a Commission proposal for an EU regulation on standards of quality and safety for substances of human origin intended for human application

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Leiden, 22 July 2022:

The EBMT is a community of hospitals and healthcare professionals specialised in stem cell transplantation and cellular therapies. We are focused on innovation, research and the advancement of cellular and stem cell-based therapies to save and improve the lives of patients with blood-related disorders.

Whilst EBMT members are still reviewing the comprehensive proposal, EBMT broadly welcomes the Commission proposal for an EU regulation on standards of quality and safety for substances of human origin intended for human application, published on 14th July.[1]

We particularly welcome the introduction of the joint regulation approach, which will require blood and tissue establishments to follow technical guidelines developed and maintained by expert bodies, in order to build upon established expertise in the field of substances of human origin (SoHO). This will harmonise standards across the EU and thus remove barriers to exchange of SoHO, while the agility of the framework will allow it to respond to changes in science and practice in this constantly progressing field. We appreciate that the principle of voluntary unpaid donations has been maintained and that donor protection measures have been strengthened. 

We also welcome the establishment of a SoHO Coordination Board that will create clarity and improve interplay where SoHO become starting materials for ATMPs and other therapies manufactured under different legal frameworks, thereby contributing to a regulatory environment that enables the development of curative approaches to very serious and frequently fatal diseases. As one of the leading medical and scientific organisations for cellular and stem cell-based therapies, EBMT supports a harmonised risk-assessment based authorisation process and clinical outcome monitoring proportionate to the identified risks to contribute to improving the lives and quality of care of patients with blood-related disorders.

EBMT looks forward to reviewing the proposed regulation in detail before agreeing a final position and to contributing to the ongoing legislative process.    


[1] Proposal for Regulation of the European Parliament and of the Council on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC:  https://health.ec.europa.eu/blood-tissues-cells-and-organs/overview/proposal-regulation-substances-human-origin_en