Member: Maija CirkinaAlternate: Iveta Eglite State Agency of MedicinesJersikas iela 15LV-1003 RIGA

Gateway XML FileHandler and PSUR Repository services will be unavailable for several hours due to planned maintenance activities.

ICH has published the final training module, “Implementation Guide for Electronic Transmission of Individual Case Safety Reports, Module III” for Guideline E2B(R3), one of several related guidelines on Clinical Safety Data Management.

Chairperson:  Priscilla Schoondermark

Release notes for PLM Portal eAF version 1.2.1.6 have been published, outlining bug fixes and application enhancements.

Training presentations on Active Substance Master File (ASMF) work sharing procedure:

The ICH M4Q(R2) Expert Working Group has developed a mock example to illustrate the potential structure and presentation of information in the revised Modules 2.3 and 3 of the Common Technical Document – Quality.

Pneumovax and associated names (pneumococcal polysaccharide vaccine)UK/W/0078/pdWS/001End of procedure: 08/11/2014Date of publication: 30/01/2015DE/W/0080/pdWS/003End of procedure: 18/08/2022Date of publication: 25/10/2022DE/W/0080/pdWS/004End of procedure: 28/11/2025Date of publication: 10/02/2026

The ICH M15 Guideline, General Principles for Model-informed Drug Development, has been adopted and will now enter the implementation phase.

Report from the meeting held on 27-28 January 2026