The International Council for Harmonisation (ICH) recently adopted Annex 2 of ICH E6(R3): Good Clinical Practice, concluding the revision of this essential ICH Guideline.

Doxazosin mesilate, finasteride (MIP Pharma) / Doxazosin mesilate, finasteride (Viatris)Date of publication: 03/07/2026

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.

CMDh Multi-annual Workplan to 2028 (March 2026)

Ramipril/indapamideDate of publication: 07/04/2026