Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea; Department of Life Science, University of Seoul, Seoul, South Korea.
Biopharmaceutical & Herbal Medicine Evaluation Department, National Institute of Food and Drug Safety Evaluation, Ministry of Food and Drug Safety, Cheongju, South Korea.
Biologicals. 2024 May;86:101768. doi: 10.1016/j.biologicals.2024.101768. Epub 2024 May 10.
Plasma-derived medicinal products (PDMPs) are essential in the treatment of acute and chronic life-threatening diseases. The Korea Ministry of Food and Drug Safety has conducted a national lot release (NLR) of PDMPs since 2012 based on a summary protocol review system and lot release testing. However, few studies have investigated the performance or characteristics of the NLR framework. Over the past decade, the NLR of PDMPs was approximately 1000 per year, including mainly albumins, immunoglobulins, fibrin sealant kits, and coagulation factors, among others. The NLR system for PDMPs is similar to that for vaccines, except that PDMPs are manufactured using human plasma, which requires strict safety management. This study describes the status of NLR procedures for PDMPs and outlines the regulatory requirements needed to safely manage plasma for fractionation in Korea. This study can aid national control laboratories and marketing authorization holders in developing regulatory systems that assure the availability of safe and effective PDMPs.
血浆衍生药品（PDMPs）在治疗急性和慢性危及生命的疾病方面至关重要。自 2012 年以来，韩国食品药品安全部一直基于总结性方案审查系统和批放行检测对 PDMP 进行国家批放行（NLR）。然而，很少有研究调查 NLR 框架的性能或特点。在过去十年中，PDMP 的 NLR 每年约为 1000 批，主要包括白蛋白、免疫球蛋白、纤维蛋白密封套件和凝血因子等。PDMP 的 NLR 系统与疫苗的 NLR 系统相似，不同之处在于 PDMP 是用人血浆制造的，这需要严格的安全管理。本研究描述了 PDMP 的 NLR 程序的现状，并概述了在韩国安全管理用于分离的血浆所需的监管要求。本研究可以帮助国家控制实验室和上市许可持有人制定监管系统，以确保安全有效的 PDMP 供应。
