Artificial blood made from stem cells is classified as an advanced biopharmaceutical. It becomes possible to enter clinical trials, obtain product approval, and manufacture products. The Ministry of Food and Drug Safety revealed this on the 8th.
Artificial blood is noted as a means to prepare for the shortage of blood due to low birth rates and an aging population. It involves creating red blood cells that carry oxygen and platelets that help with blood clotting from stem cells. The government has been developing cell-based artificial blood technology since 2023, investing 48.1 billion won.
Until now, there have been no guidelines or regulations for cell-based artificial blood. This is because domestic blood management law defines blood only as blood cells and plasma collected from the human body. The Ministry of Food and Drug Safety believes that this issue can be resolved through the classification of advanced biopharmaceuticals.
The Ministry of Food and Drug Safety noted, "Once the development of cell-based artificial blood is completed, it will be able to respond to special demands such as rare blood types and patients with thrombocytopenia, in addition to blood donations."