SoHO oversight system: the implementation of the new EU regulation with a focus on the obligations for competent authorities

The event “SoHO oversight system: the implementation of the new EU regulation with a focus on the obligations for competent authorities” was held on April 8th at the Istituto Superiore di Sanità.

On July 17th, 2024, the new European regulation on standards of quality and safety for substances of human origin intended for human application and repealing Directives 2002/98/EC and 2004/23/EC was officially published in the EU Official Journal.

The adoption of this new legal act is the result of a challenging revision process launched by the European Commission with an evaluation of the legislation related to blood, tissues and cells, and medically assisted reproduction. The impact assessment consisted of public and stakeholders consultations, including the organisation of dedicated workshops, as well as two external studies. Commission Expert Sub-Groups on Inspections and Vigilance (IES, VES) have been set up and other European initiatives
such as VISTART, GAPP, GAPP-PRO and SIGHTSoHO have been launched to improve and harmonise SoHO oversight activities. Moreover, stronger collaboration has been sought with the European Centre for Disease Prevention and Control (ECDC) and the European Directorate for the Quality of Medicines & HealthCare
(EDQM), who play a key role within the new legislation.

Objective
The conference had the following objectives:

• Present the experience of some blood competent authorities in the process that will lead each member state, over the next 3 years, to comply with the new regulation.
• Presenting the state-of-the-art of tools and means at the EU level to support MS in the implementation of the regulation;
• providing an overview of the key European initiatives and actions;
• discussing the strengths and obstacles to a common European approach in the oversight activities.

For further info
Definitive programme

Presentations