New Regulations on Adverse Events
According to the regulation of MHLW, any adverse event must be reported using designated terms called "Adverse Event Glossary." In 2021, this glossary was organized to align with the IMDRF's terminologies for categorized Adverse Event Reporting (AER): Terms, Terminology Structure, and Codes, promoting greater harmonization with global regulations.
On April 13th, 2022, MHLW announced amendments to this Adverse Event Glossary, ensuring it aligns 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: