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SLP review system for vaccine products will start
At present, National Assay is conducted for
veterinary vaccines in Japan. When a product is officially approved, tests for
National Assay are picked up from QC tests of the final product which described
in its application and related to safety and efficacy mainly.
Recently, it was announced from responsible
ministry to marketing authorization holders National Assay will be replaced by
SLP review system by 2020, when Tokyo Olympic is scheduled. Now, National Assay
Laboratory where belongs to Ministry of Agriculture, Forestry and Fishery is
announcing in the web site that trial of SLP review is on going (only Japanese
announce is available). After National Assay is eliminated, reduction of
product cost and speedy supply of products are expected.