On July 17, 2024, the Regulation (EU) 2024/1938 on standards of quality and safety for substances of human origin intended for human application was published. The new Regulation promotes high quality and safety standards, enhanced protection of donors and patients, harmonisation across Member States, continuity of supply and preparedness for emergency situations.

Future developments in quality management and the accompanying challenges will be influenced by the changed legislative framework, but more in terms of strengthening or expanding the existing requirements than introducing new requirements or significantly changing existing practices. By referring to the EDQM and ECDC guidelines to achieve compliance with the standards set out in the Regulation, timely alignment with scientific progress and best practices as well as a timely response to new threats is enabled. Adapting to more rapid changes may prove challenging for the quality management system, which should ensure timely, controlled, and documented implementation of new or changed requirements and maintain an adaptable monitoring system.

The new Regulation places a strong emphasis on SoHO preparation authorization, risk management and emergency planning. In addition, traceability and vigilance requirements have also been enhanced. Quality management staff will play an important role in supporting the implementation of these requirements, setting priorities, coordinating activities, creating documents, etc. Even in well-developed quality systems, it will be necessary to provide additional education and training of staff, and if necessary, other resources for the effective implementation of all requirements.

International cooperation will become increasingly important in the harmonization of standards and definitions, quality monitoring and benchmarking, and sharing of best practices.