분획용 혈장 안전관리를 위한 원료혈장 마스터 파일 정책에 대한 고찰

• 영문명: An Investigation into the Plasma Master File Policies for the Safety Management of Plasma for Fractionation
• 발행기관: 대한약학회
• 저자명: 최찬웅(Chan Woong Choi) 최영주(Youngju Choi) 김영훈(Young Hoon Kim)
• 간행물 정보: 『약학회지』제68권 제6호(2024년), 487~494쪽, 전체 8쪽
• 주제분류: 의약학 > 기타의약학
• 파일형태: PDF
• 발행일자: 2024.12.31

국문 초록

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.

목차

서 론(Introduction)

방 법(Methods)

결과 및 고찰(Results and Discussion)

결 론(Conclusion)

감사의 말씀(Acknowledgment)

Conflict of Interest

References

키워드

Plasma mater file Plasma for fractionation Plasma-derived medicinal products

참고문헌

• Blood Transfusion
• Transfusion
• The Korean Journal of Blood Transfusion
• International Society of Blood Transfusion Science Series
• Annals of Blood
• Journal of the Pharmaceutical Society of Korea
• Biologicals
• Biologicals