Get Involved in IMPLEMENT-SoHO: Helping Europe Prepare for the New SoHO Regulation

EBMT has announced its active participation in the IMPLEMENT-SoHO project, a new European initiative designed to support professionals and organisations working with Substances of Human Origin (SoHO) as Europe prepares for a major regulatory transition. The project is funded under the #EU4Health Programme and is run by the European Health and Digital Executive Agency (HaDEA) on behalf of DG SANTE.

At the heart of the initiative is practical readiness for the new Substances of Human Origin Regulation (EU) 2024/1938, which is set to apply from August 2027. IMPLEMENT-SoHO aims to help SoHO professionals across the EU anticipate the new requirements and strengthen preparedness through a combination of targeted training, cross-border exchange visits, and evidence-based scientific guidance. The overarching goal is to help maintain high standards in quality, safety and supply of therapies derived from Substances of Human Origin.

As a key partner, EBMT will contribute sector-specific expertise and act as a bridge between the project and the wider professional community. A central element of EBMT’s role will be dissemination: EBMT will lead a pan-European digital campaign to increase awareness of voluntary and unpaid SoHO donation. This work is intended to support self-sufficiency of supply across the EU and the European Economic Area (EEA), reinforcing sustainability and resilience in access to therapies.

Importantly, the project is positioned to support professionals involved in implementing the SoHO Regulation in their organisations—regardless of which specific part of the Regulation they are working on. Whether your focus is on registration, authorisations, vigilance, donor protection, or other operational and compliance topics, the project intends to develop capacity-building support that is relevant to real-world implementation challenges.

The first concrete activity is already underway: an online survey open from 19 May to 7 June. The questionnaire covers participants’ familiarity with the SoHO Regulation, perceived implementation barriers, and priority training needs. EBMT emphasises that responses will directly shape the capacity-building activities ultimately delivered by IMPLEMENT-SoHO—making this an early opportunity for professionals to ensure that future support is aligned with day-to-day realities.

Finally, EBMT encourages interested stakeholders to follow the project on LinkedIn and explore the project overview to stay informed as the programme develops. With regulation timelines approaching, IMPLEMENT-SoHO offers a timely forum for collaboration, shared learning, and practical preparation across Europe’s SoHO community. Read more about IMPLEMENT-SoHO on the website.