The European Directorate for the Quality of Medicines & HealthCare (EDQM) of the Council of Europe welcomes the recent provisional agreement reached between the European Parliament and the Council of the European Union (EU) on the draft regulation on blood, tissues and cells. This marks a pivotal step towards harmonising quality and safety standards for substances of human origin (SoHO) across the EU. This provisional agreement will now have to be endorsed by the Council and the Parliament.
The new regulation, whose broad scope covers all SoHO, including faecal microbiota and human breast milk, will enhance the protection of both donors and recipients. With this in mind, it will further build on existing expertise, notably that of the European Centre for Disease Prevention and Control (ECDC) and the EDQM, both of which have extensive experience in the development of technical guidelines that keep pace with the latest scientific developments.
The EDQM is a major player in developing guidelines as well as providing capacity-building tools, and stands ready to support SoHO establishments in implementing the new regulation.
This promising development emphasises the commitment the European institutions share with the EDQM to reinforce the SoHO healthcare systems in the European Union and beyond.