Release notes for PLM Portal eAF version 1.2.1.7 have been published, detailing bug fixes and functional improvements delivered in the March 2026 production release.

Member: Katrine Damkjær MadsenAlternate: Therese Langkjær Danish Medicines AgencyAxel Heides Gade 1DK-2300 COPENHAGEN

Final EU eCTD v4.0 Validation Criteria version 1.1 has been released, introducing updated validation rules applicable from 15 July 2026.

Users are reminded to verify selected variation scopes and supporting documentation when using the updated variation classification implemented in both PDF and PLM Portal eAF forms.

Benzocaine / TyrothricinEnd of procedure: 28/02/2025Date of publication: 04/03/2026

CMDh Multi-Annual Workplan to 2025 - Summary Report (February 2026)

Gateway XML FileHandler, Delivery File UI and PSUR Repository services will be temporarily unavailable during scheduled maintenance.

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.