SoHO Regulation - Overview and Impact - Online Training Recording

This seminar aims to provide participants with a clear understanding of the motivation, scope, and structure of the new EU SoHO Regulation. Participants will learn to correctly interpret key definitions, roles, and delineations within the SoHO framework. Participants will also gain insight into the regulatory impact on cell and gene therapies. This includes changes related to autologous and allogeneic donations, the use of SoHO as starting materials, and associated quality management system requirements. Additionally, the seminar will address the consequences for blood donation and plasma collection. There will be a particular focus on the regulatory interfaces between collection and manufacturing, as well as import and export requirements. The seminar will also address the opportunities and challenges that arise during the transition to the new regulatory requirements.

Background
The European Union is introducing a harmonized and horizontal regulatory framework covering blood, plasma, cells, and tissues for the first time with the new Regulation on Substances of Human Origin (SoHO). The regulation aims to strengthen patient safety and the quality and security of the supply chain, while replacing the existing directive-based regulatory landscape.

After several years of legislative discussion and stakeholder consultation, the SoHO Regulation was formally adopted in 2024.It entered into force shortly thereafter, but its binding application will not take effect until 7 August 2027. This allows member states, competent authorities, and affected organizations sufficient time to adapt existing structures, processes, and quality systems to the new requirements.
The regulation significantly impacts established processes, from donation and collection to the use of substances of human origin as starting materials for medicinal products, particularly for cell and gene therapies. Blood and plasma establishments will also be affected by new requirements, especially with regard to quality management systems, regulatory interfaces, and import and export activities.

While the transition period presents considerable challenges, it also offers opportunities for harmonization and optimization of processes across the EU. But what exactly is the impact on different areas? This seminar will answer this question and many others.