According to the regulation of MHLW, any adverse event must be reported using designated terms called “Adverse Event Glossary”. In the year of 2021, this “Adverse Event Glossary” was arranged in a way that matches with the IMDRF’s terminologies for categorized Adverse Event Reporting (AER): Terms, Terminology structure and Codes, to seek more harmonization with the global regulations.
On April 13th, 2022, MHLW announced that this Adverse Event Glossary was amended to harmonize with the newest edition of the IMDRF terminologies for categorized Adverse Event Reporting (AER): Terms, Terminology Structure and Codes. Please kindly check the links below for the mapping chart of MHLW’s Adverse Event Glossary and IMDRF’s terminologies.
MHLW’s notice on amendment on Adverse Event Glossary
PMDA’s webpage for each Annex of the Glossary
MHLW’s notice: reporting adverse events