European Regulation Substance of Human Origin (SoHO)

The Agence de la biomédecine is actively involved in drafting the new EU regulation on quality and safety standards for Substances of Human Origin (SoHO). This new regulation marks a milestone in the regulation of the use of substances of human origin for therapeutic purposes, by broadening its scope and harmonizing quality and safety standards across the European Union.

Since 2004, two directives have formed the basis of European regulations governing the use of tissues, cells and blood. The scope of the SoHO regulation now extends to all substances of human origin intended for human application, including tissues and cells, as well as gametes falling within the remit of the Agence de la biomédecine (excluding organs).

It was the shortage of products and substances of human origin, amplified since the Covid-19 pandemic, that gave rise to the need to harmonize the different rules within the member states of the European Union. Until now, there have been too many discrepancies in the way directives have been transposed - creating obstacles to the sharing of SoHO within the Union. The new regulation will apply in its entirety and directly in all member states from 2027. In addition to this expansion, the regulation introduces structural measures:

• The creation of a European digital platform centralizing vigilance information to provide a real-time overview.
• Harmonized standards and registration of all entities involved in SoHO-related activities
• Reinforced expertise, drawing on existing technical bodies such as the ECDC and EDQM.
• Setting up a SoHO coordination committee to provide legal support and recommendations to accompany implementation.
• Measures to support supply in the event of shortages of critical substances.

In France, the Agence de la biomédecine played a central role with the Ministry of Health in the run-up to the regulation, highlighting the specific issues for each area of competence: tissues, cells, gametes and vigilance with other French players, such as the Agence nationale de sécurité du médicament et des produits de santé (ANSM) and the Établissement français du sang (EFS). Agence de la biomédecine (A.B.M.) emphasized the importance of French expertise, with its strict framework, and ensured that the text remained close to the reality in the field. The Agence de la biomédecine is due to implement these regulations on its territory by 2027.