New EU Regulation on Substances of Human Origin

June 13, 2024

EU Regulations


A new Regulation on standards of quality and safety for substances of human origin (SoHO) intended for human application is scheduled to be signed by the EP and the Council of the EU today. It is expected to be published in the Official Journal of the EU soon after it is signed. This new Regulation will repeal the current Blood Directive 2002/98/EC and the Tissues and Cells Directive 2004/23/EC.

The regulation defines SoHOs as “any substance collected from the human body, whether it contains cells or not and whether those cells are living or not, including SoHO preparations resulting from the processing of such substance.” The regulation covers the use of SoHOs in medicines, advanced therapies, starting materials for producing investigational medicinal products, and stem cell transplants for blood cancers and other conditions.

The new Regulation:

  • Supports the continued provision of SoHO therapies, now and in the future, based on high safety and quality standards and up-to-date technical rules,
  • Extends protective measures to new groups of patients, to donors and to offspring born from medically assisted reproduction,
  • Improves harmonisation across Member States, facilitating cross-border exchange of SoHO and improving patient access to the therapies they need,
  • Creates conditions for safe, effective and accessible innovation in a unique sector driven by public health services and voluntary and unpaid donations,
  • Improves crisis preparedness and resilience to safeguard access to therapies,
  • Implements digital-ready policies,
  • Contributes to the European Health Union by pooling of technical expertise and achieving economies of scale.

The new regulation requires EU Member States to designate a SoHO national authority and other competent authorities to authorise SoHO preparations and ensure independent and transparent oversight of SoHO related activities.

The regulation also sets out further requirements for authorisation and inspection of establishments that process and store, release, import and export such substances.

A rapid alert system is to be set up to deal with serious reactions and incidents affecting recipients or donors.

Member States are also encouraged to create national emergency plans to include measures to respond to critical shortages.