PMDA E2B(R3) updates

Summary

PMDA E2B(R3) updates (Enhancement 36191301)

Description

PMDA E2B(R3) is updated as per the J Item OID and code list published on 17-Jan-2024 as below:
  • A new code list value, Phase I/III (第Ⅰ/Ⅲ相), is added to Console > Code list > Argus > Study Development Phase.

    This code list is added as Allowed Value for MHLWPHASEOFSTUDIES[J2.13.r.3] for PMDA E2B(R3) profile.

  • The E2B_R3 code for DEV_PHASE in Console > Code list > Flexible Data Re-Categorization is set to 6.
  • The MHLWPHASEOFSTUDIES[J2.13.r.3] [Ver] is updated from 1.1 to 1.2.

For more information, refer to ArgusInterchange844_PMDA E2B(R3) Export Import Mappings.xlsx.