The ICH M11 Expert Working Group has issued a final overview presentation (at Step 4 of the ICH harmonisation process) for ICH M11: The Clinical electronic Structured Harmonised Protocol (CeSHarP), a guideline adopted in November 2025.
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
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.
Member: Katrine Damkjær MadsenAlternate: Therese Langkjær Danish Medicines AgencyAxel Heides Gade 1DK-2300 COPENHAGEN
Benzocaine / TyrothricinEnd of procedure: 28/02/2025Date of publication: 04/03/2026
CMDh Multi-Annual Workplan to 2025 - Summary Report (February 2026)
Member: Maija CirkinaAlternate: Iveta Eglite State Agency of MedicinesJersikas iela 15LV-1003 RIGA