우리나라와 일본의 분획용 원료혈장 관련 규제 현황 비교

The Regulatory Framework for Source Plasma: Comparison of South Korea and Japan

The blood business in Korea has established a governance system based on the Blood Management Act (BMA) and Pharmaceutical Affairs Act (PA). The Korean government has constructed a non-profit securing and supplying system for blood recommended by the WHO. In recent years, the blood self-sufficiency rate is decreasing due to the aging population, increasing the number of indications of plasma-derived medicinal products (PDMPs). It is predicted that the number of people who can voluntarily donate blood is decreasing due to the prolonged COVID-19. Plasma for fractionation (PF) is used as a raw material to manufacture PDMPs that include albumin, immunoglobulins, and clotting factors. The United States is the largest supplier of PF in the world, and Korea imports PF from the United States to meet domestic demand. Although the FDA licenses plasma from the United States, it is vital to confirm the safety and quality of imported plasma. Manufacturing quality management of PF products is carried out in most developed countries based on the GMP guidelines; however, each country has different governance systems. This study compared the Japanese regulatory system with the Korean system to draw implications for improving the efficiency of plasma regulation in Korea.