Annual report 2023 on the supervision of the quality and safety of transplants 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, tissue transplants, germ cell and stem cell transplants, and organ transplants 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 2023, the division processed 45 organ transplantation permits, 38 operational change notifications and 104 serious adverse events or adverse reactions reported in SoHO activities, 36 of which took place in another EU country. In addition, 33 inspections of blood service and tissue establishments were carried out.

Among other things, Fimea-controlled operators reported almost 200,000 blood products, 475 organ transplants, 403 stem cell transplants and around 1,900 patients treated with tissue transplants. In 2023, a total of 1,202 fertility treatments for female couples or single women were performed. The majority of fertility treatments with donated sperm were carried out with imported sperm.

Read more:

Fimea’s supervision of the use of transplants of human origin in 2023 (pdf)