Japanese–English glossary
Shelf life
Also called period of validity
有効期間yūkō kikan
The period during which a product, stored as specified, is assured to remain within specification, set from stability data. In a Japanese marketing approval application it sits in the column for storage method and shelf life (貯蔵方法及び有効期間), so extending it changes an approved matter and needs a filing. The expiry date on the label is derived from it. Watch for a false friend: the same Japanese word is used for the validity period of licenses and accreditations, such as the five-year validity of an Accreditation of Foreign Manufacturers. For cell therapy products the shelf life can be very short, which shapes release testing and logistics.