E-labeling system in prescription medicines in Japan: measures and perspectives in pharmaceutical industry
Makoto Nagaoka, Tamaki TAKAMINE
Abstract
In Japan, digitization of the package insert was stipulated in the Act on Securing Quality, Efficacy, and Safety of Products Including Pharmaceuticals and Medical Devices, amended in December 2019 and enforced on August 1, 2021. Therefore, it is possible to access the contents of the package insert that are posted on the Pharmaceuticals and Medical Devices Agency website by scanning the GS1 barcode on the outer box of the drug with a smartphone application. Additionally, the inclusion of paper package inserts in products will be abolished by the end of July 2023. The digitization of the package insert will present benefits such as convenience in utilization of package inserts, access to the latest package inserts, and saving of paper resources, despite some challenges remaining. Further linkage with other healthcare information is expected to be promoted in addition to solving these challenges.