Kato Atsushi, Fujita Kentaro, Ochiai Masaki, Naito Seishiro, Konda Toshifumi
Department of Quality Assurance and Radiological Protection, National Institute of Infectious Diseases.
Antimicrobial Resistance Research Center, National Institute of Infectious Diseases.
Jpn J Infect Dis. 2019 May 23;72(3):133-141. doi: 10.7883/yoken.JJID.2018.446. Epub 2018 Nov 30.
Biological products, such as vaccines, blood products, antitoxins, and antivenoms, are released into the market following a lot release conducted by National Regulatory Authorities or National Control Laboratories, even if their manufacturing and marketing have been authorized. Independent lot release by regulatory authorities is not a procedure unique to Japan, but is performed worldwide. Previously, Japan carried out lot release mainly by laboratory tests, and the manufacturers' in-house test records were used as a reference, not involved in the decision of lot release. Conversely, the international standard procedure promoted by the World Health Organization (WHO) includes a document review of the manufacturers' summary protocols, and laboratory tests are listed as an optional procedure. To harmonize with the WHO recommended international method, Japan modified the procedure and introduced a document review in addition to laboratory tests for vaccines in 2012. Since then, substantial knowledge regarding vaccine quality has been obtained during the process of summary protocol reviewing. Here, we outline the current status of the lot release procedure in Japan. We shed light on its history and show recent research based on the knowledge obtained from the protocol review to improve efficiency of laboratory testing and international harmonization.
生物制品，如疫苗、血液制品、抗毒素和抗蛇毒血清，即使其生产和销售已获授权，仍需在国家监管当局或国家控制实验室进行逐批放行后才能投放市场。监管当局的独立逐批放行并非日本独有的程序，而是在全球范围内实施。以前，日本主要通过实验室检测进行逐批放行，制造商的内部检测记录仅作为参考，并不参与逐批放行的决策。相反，世界卫生组织（WHO）推广的国际标准程序包括对制造商总结方案的文件审查，实验室检测则列为可选程序。为与WHO推荐的国际方法保持一致，日本于2012年修改了程序，除了对疫苗进行实验室检测外，还引入了文件审查。自那时以来，在总结方案审查过程中获得了大量有关疫苗质量的知识。在此，我们概述了日本逐批放行程序的现状。我们阐述了其历史，并展示了基于从方案审查中获得的知识而开展的最新研究，以提高实验室检测效率和实现国际协调。
