EMA introduced readable RMS identifiers in the European Shortages Monitoring Platform to simplify data entry, improve reporting accuracy and enhance overall user experience.

EMA launched a user survey to gather feedback on adoption, usability, support resources and overall experience with the PLM Portal web-based electronic Application Form, with responses requested by 24 April 2026.

EMA announced that PLM web-based eAF will become mandatory for Centrally Authorised Product variation submissions from 1 September 2026, replacing PDF eAF except in justified technical limitation scenarios.

ICH has issued an overview training module for harmonised Guideline ICH M15: General Principles for Model-Informed Drug Development. The M15 Guideline was adopted in January of this year.

Summary of CMDh activities 2025

CMDh Multi-annual Workplan to 2028 (March 2026)

Ramipril/indapamideDate of publication: 07/04/2026

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.