Blood, Blood Products and Plasma Quality, Safety, SoHO and recent Developments

In July 2022, the European Commission adopted the proposal for a Regulation on standards of quality and safety of substances of human origin intended for human application. The Council agreed on its negotiating mandate in October 2023. Negotiations with the European Parliament began in November 2023 and conclude with provisional agreement since Dec 2023. With the repeal of the Blood Directive (2002/98/EC) and the Tissues and Cells Directive (2004/23/EC), the Regulation finalizes the revision of the regulatory framework for blood, tissues and cells in the light of new scientific, technical and societal developments. It aims to prioritize and ensure donor safety, patient safety, security of supply and the development of innovative medical procedures in Europe. 

Furthermore, the EU GMP Guideline, Annex 1 „Manufacture of sterile medicinal products“ also came into effect on 25 August 2023.

But what impact will these two new regulations have on donation centres and on companies that manufacture blood and plasma products in Europe? A harmonized regulation is essential for patient safety as well as the quality of the products, but new regulations often raise many questions and should definitely be clarified before inspection by the authorities.

Take the opportunity to exchange experiences with experts at this event and also talk about new developments, e.g. in analytics, production, products and existing issues and problems, e.g. inspections, blood labeling and more.