EMA released Veterinary MAA eAF version 1.28.0.0 for broader user testing, introducing VMP Regulation alignment, SRP support and improvements based on the ISO IDMP data model.

EMA confirmed that Human MAA eAF version 1.28.0.0 must be used for new CAP MAA submissions from 28 July 2026 and announced a future wider rollout for other submission types.

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 [...]

EMA released Human MAA eAF version 1.28.0.0 for user testing, introducing structural enhancements aligned with the ISO IDMP data model and improved representation of medicinal product information.

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.

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.