Interactive PDF electronic application forms will be unavailable from 10 to 12 April 2026 due to OMS, RMS and SMS maintenance activities. PLM Portal eAF will remain operational.

ICH has published an updated and expanded Q9(R1) Quality Risk Management Briefing Pack to support the implementation of a systematic approach to quality risk management in pharmaceutical development, manufacturing and distribution.

EMA has started Phase III of the eCTD v4.0 forward compatibility pilot, allowing applicants to test lifecycle transformation and document reuse scenarios for Centrally Authorised Products.

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.