On 17 July 2024, the new Regulation on standards of quality and safety for substances of human origin intended for human application has been published on the Official Journal of the EU.
The Regulation was adopted by the Council on 27 May 2024 and approved by the European Parliament on 24 April 2024.
The Commission Proposal was tabled in July 2022.
The new EU rules will:
- support the continued provision of SoHO therapies, now and in the future, based on high safety and quality standards and up-to-date technical rules
- extend protective measures to new groups of patients, to donors and to offspring born from medically assisted reproduction
- improve harmonisation across Member States, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need
- create conditions for safe, effective and accessible innovation in a unique sector driven by public health services and voluntary and unpaid donations
- improve crisis preparedness and resilience to safeguard access to therapies
- implement digital-ready policies
- contribute to the European Health Union by pooling of technical expertise and achieving economies of scale.
Commission proposal
The dedicated webpage for the revision process of the blood, tissues and cells directives, as well as the impact assessment report (Commission SWD and its annexes, and executive summary) provide further details.
The measures taken in the proposal were examined in a thorough impact assessment consisting of
Next steps
The new Regulation will apply as from 7 August 2027, 3 years after its publication and entry into force, with an extra year for certain provisions.
