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.

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