국내 혈장분획제제 안전관리 정책과 특성에 대한 고찰

Abstract

Plasma-derived medicinal products (PDMPs) are pharmaceuticals prepared using proteins in plasma, a liquid component of blood. Regarding the use of human blood as a raw material in PDMP manufacturing, it has unique characteristics unlike other pharmaceuticals (for example, limitations of scientific identification, finiteness of blood, and risk of infection through disease pathogens, such as the human immunodeficiency virus, hepatitis B virus, and hepatitis C virus in the blood). The safety management policy of PDMPs in Korea started with the enactment of the Blood Management Act in 1970. After that, the current safety management system was established through product approval management according to the Pharmaceutical Affairs Act in 2006, higher standards of safety management for imported source plasma in 2009, and expansion of management standards for source plasma in 2012. The safety management of PDMPs involves several important policies. Public management has been carried out by the Korean Red Cross and national government, and domestic plasma should be used first, while imported plasma may be used only if there is not enough. Additionally, to ensure blood products safety, plasma testing, inventory hold, and plasma master file reporting obligations are being implemented. In addition, it is managed as a subject of national lot release, which should also be quality-confirmed by the country. Because the supply of domestic source plasma, which is the raw material of PDMPs, has shown a decreasing trend in recent years, continuous monitoring and preparation is required. In this study, we describe the history of safety management policies, including the definition and classification of PDMPs, product status, usage status of source plasma, and the related policy guidelines and characteristics.