EMA updated the eCTD v4.0 implementation roadmap, announcing strongly recommended use for new CAP MAAs from Q1 2027, mandatory use from Q1 2028, and continued pilot activities.

Release notes for version 1.2.1.14 are now available, covering bug fixes, the Annual Update checkbox functionality and support for FHIR XML version 2.2.6.

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

EMA published mandatory use timelines for Human and Veterinary MAA eAF version 1.28.0.0, including CAP submissions from July 2026 and wider NCA adoption through 2027.

EMA announced a FHIR XML upgrade introducing support for the Annual Update notification while maintaining compatibility with the existing FHIR package.

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.

Efluelda Tetra (quadrivalent influenza vaccine (split virion, inactivated), 60 micrograms HA/strain)End of procedure: 14/04/2026Date of publication: 27/05/2026