Study on the Procedure for Lot Release of Vaccines in Japan.

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.