ICH E2B(R3) Implementation Guide updates—July 2025 revision

Summary

ICH E2B(R3) package v1.10 updates for the dose/strength units (Enhancements 39413913).

Description

Argus Safety is enhanced to align with the Dose and Strength Unit flags introduced in the ICH E2B(R3) package v1.10 (E2B CL25: ICH-DOSESTRENGTH-UNIT codelist).

Changes include:

• Updated the Dosage Unit codelist to incorporate the Dose and Strength Unit flags as per the ICH codelist.
• Updated the allowed values for the following E2B(R3) elements in the ICH, MFDS, and NMPA profiles:
  • DRUGSTRUCTUREDOSAGEUNIT [G.k.4.r.1b]
  • DRUGCUMULATIVEDOSAGEUNITR3 [G.k.5b]
  • STRENGTHUNIT[G.k.2.3.r.3b]

Note:

The FDA and PMDA E2B(R3) profiles are not updated as these authorities are yet to confirm their adoption to dose and strength unit updates.