분획용 혈장 안전관리를 위한 원료혈장 마스터 파일 정책에 대한 고찰

An Investigation into the Plasma Master File Policies for the Safety Management of Plasma for Fractionation

Efforts to achieve self-sufficiency in plasma-derived medicinal products (PDMPs) are actively underway in many countries that lack plasma fractionation technologies, with a focus on utilizing domestic plasma through contract plasma fractionation. These countries are looking to benchmark the plasma master file (PMF) policies of Korea, a key producer of PDMPs in Asia. This study examines the current status of plasma for fractionation and PDMPs in Korea, explores domestic and international PMF and plasma for fractionation policies, and reviews the key regulatory perspectives of national regulatory authorities on PMF evaluations. The study includes a comparative analysis of relevant legislation and guidelines from Korea, the European Union, the World Health Organization (WHO), and the United States of America. Korea’s PMF consists of general information (summary), details on blood and plasma collection, and plasma quality and safety, harmonized with European Union’s requirements. The WHO emphasizes the importance of national regulatory oversight in managing PMF-related elements. The United States of America does not employ a PMF system; instead, the Food and Drug Administration sets minimum requirements in the Code of Federal Regulations, with more detailed voluntary standards established by blood and plasma associations. Among various plasma for fractionation safety management policies, the PMF plays a crucial role in bridging the complex relationships between PDMPs and blood establishments. As Korea faces an increasing proportion of imported plasma due to declining domestic donations and rising exports of domestic products, it is crucial to continuously monitor global policy trends regarding the management of plasma for fractionation.