A next Step for the SoHO (Standards of Quality and Safety for Substances of Human Origin) Regulation

On May 27, 2024, EU member states adopted groundbreaking regulations to enhance the safety and quality of blood, tissues, and cells in healthcare. The SoHO Regulation aims to improve safety standards and facilitate the cross-border exchange of these substances within the EU.

Key elements of the regulation include:

- Extended Scope: Inclusion of breast milk and gut microbiotics.

- SoHO Coordination Body (SCB): Assists member states in implementing the regulation.

- Common EU Procedures: Standardized authorization and evaluation of SoHO preparations.

- National SoHO Authorities: Appointment of independent supervisory bodies.

- Additional Requirements: Strict standards for processing, storing, and transporting SoHO.

- EU SoHO Platform: New IT system for registration and information sharing.

- Rapid Alert System: Mechanism for responding to serious incidents or reactions.

While SoHO donations must be voluntary and free of charge, living donors may receive compensation per national laws. The regulation, effective mid-2027 after being signed by the Council and European Parliament, will include measures to ensure the adequate supply of critical SoHO and national contingency planning.