2024 annual report on the supervision of the quality and safety of substances of human origin has been published

Fimea's Substances of Human Origin (SoHO) division is responsible for supervising the quality, safety and traceability of transplants of human origin, such as blood products, tissues, gametes, stem cells, and organs in Finland. The supervision covers licence procedures and the maintenance of operator registers, the regular inspection activities and the monitoring of serious adverse events and adverse reactions observed in the activities. 

In 2024, the division processed 20 operational change notifications, and 169 serious adverse events or adverse reactions reported in SoHO activities. In addition, 35 inspections of blood and tissue establishments and organ donor hospitals were carried out.

Among other things, Fimea-controlled operators reported almost 180,000 blood products, 449 organ transplants, 475 stem cell transplants and around 2,900 patients treated with tissue transplants. 

A significant change also took place in 2024 with the European Parliament and the Council’s adoption of a new regulation on standards of quality and safety for substances of human origin intended for human application. The implementation of the regulation will require measures from both operators and Fimea during the transition period and onward from 7 August 2027 when the regulation will be applied.

More information:

Fimea’s supervision of the use of substances of human origin in 2024 (pdf, in Finnish)

Substances of human origin (in Finnish)