The Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) met in person on 2–3 June 2026 in Rio de Janeiro, Brazil for its biannual meeting. The ICH Assembly meeting was preceded by meetings of the ICH Management Committee and the MedDRA Steering Committee on 31 May and [...]
Vaccin rabique Pasteur / Verorab (rabies virus inactivated (Wistar rabies PM/W138 1503-3M strain))End of procedure: 10/04/2026Date of publication: 27/05/2026
Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)End of procedure: 14/04/2026Date of publication: 27/05/2026
Rapibloc / Landiolol Hydrochloride Orpha-Devel (landiolol hydrochloride)End of procedure: 09/04/2026Date of publication: 27/05/2026
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.