Cell-Based Artificial Blood Classified as "Advanced Biopharmaceutical"

Ministry of Food and Drug Safety Enables Clinical Trials and Product Approval Applications for Development

The Ministry of Food and Drug Safety announced on August 8 that it has classified cell-based artificial blood, which is being developed through national R&D, as an advanced biopharmaceutical. This classification will enable the full-scale progression of the development process, including entry into clinical trials and applications for product approval.

The cell-based artificial blood technology development project has been underway since 2023. Its goal is to secure technology for producing and commercializing red blood cells and platelets from stem cells in preparation for blood supply shortages caused by low birth rates, an aging population, and the emergence of infectious diseases.

Cell-based artificial blood is a novel product with no cases of commercialization worldwide. Regulatory frameworks, such as guidelines, are lacking, and Korea's Blood Management Act defines "blood" only as blood cells and plasma collected from the human body. As a result, regulatory requirements for commercialization, including methods for evaluating safety and efficacy, have remained unclear.

In response, since last year, the Ministry has provided consulting from the early stages of development through the regulatory conformity review system, advising on regulatory requirements and strategies necessary for commercialization. After comprehensively reviewing the product's intended use, form, and mechanism of action, the Ministry decided to classify cell-based artificial blood as an "advanced biopharmaceutical" under the Act on the Safety and Support of Advanced Regenerative Medicine and Advanced Biopharmaceuticals.

This product classification now makes it possible to meet evaluation criteria, enter clinical trials, and apply for approval. If the development process is successfully completed, cell-based artificial blood is expected not only to replace donated blood but also to meet special demands, such as for patients with rare blood types and those with thrombocytopenia.

The Ministry considers this case significant, as it demonstrates how a regulatory agency can review the conformity of technology and regulations from the early stages of national innovation R&D, providing regulatory pathways for novel products that do not fit within existing frameworks, thereby reducing uncertainty and supporting ongoing development.

The Ministry stated, "In addition to artificial blood, we are expanding regulatory conformity reviews for national R&D projects developing innovative food and drug products, such as digital therapeutics for developmental disorders, gene therapies, and AI healthcare solutions. We will continue to actively support the rapid commercialization of advanced and innovative technologies so their value can be quickly delivered to the public."