The PDG focused on including the updated requirements described in the ICH Q3D Guideline and also achieved harmonisation on acceptable approaches for analytical procedures, specifically on the following topics:

• Sample preparation
• Examples of applicable procedures and detection techniques
• Requirements for procedure validation

The regional texts are expected to be published in July 2025 (Ph. Eur.), December 2025 (USP), April 2026 (JP) and July 2026 (IPC). This milestone marks the PDG’s successful harmonisation of all the general chapters on ist work programme and 48 of the 62 excipient monographs listed.

Source:

EDQM: Newsroom