Working with MHLW E2B Reports

In agXchange ESM, you can generate the MHLW E2B reports for Japanese health authorities.

In Japan, the ICSR SGML file is reported to the MHLW (Ministry of Health, Labor and Welfare) as per the ICH E2B R2 and E2B ICSR R3 Guidelines through following mediums:

• Electronic

• Floppy

• Paper submission

The specified E2B Report is attached for the floppy and paper submission. Companies also use E2B reports to check the data entry before submitting the ICSR file to the MHLW electronically.