On July 17, the Official Journal of the European Union published Regulation EU 2024/1938 (also known as the "Substances of Human Origin" (SoHO) Regulation), which sets quality and safety parameters for substances of human origin intended for human use. Approved by the European Parliament in April and definitively adopted by the EU Council in June, the regulation represents a challenge for the competent authorities of Member States. The regulation establishes the SoHO Coordination Board to facilitate the implementation of the new rules and will come into force in 2027, three years after its adoption. The regulation will ensure greater protection for recipients and donors of all substances of human origin. The new regulatory framework will require the accreditation of all entities involved in activities that may affect the quality and safety of SoHO, from laboratories to hospitals and therapeutic centers. Additionally, common evaluation and authorization procedures will be introduced, and national control, traceability, and transparency will be strengthened.