ICH and ISoP have signed a Memorandum of Understanding to formalise their strategic collaboration to strengthen global awareness, recognition and adoption of ICH Guidelines, with a focus on pharmacovigilance, medication safety and MedDRA, a standardised international medical terminology produced by ICH.
MedDRA Version 29.1 was released today in English. All 26 language translations will be available on 15 September 2026.
The ICH M8: Electronic Common Technical Document (eCTD) Implementation Working Group has issued updates to multiple support materials for eCTD v4.0 which are available for download: the Implementation Guide Package, the Controlled Vocabulary Package and the Q&A document.
2026 (Jan-Jun) - Statistics for New Applications (MRP/DCP), Variations, Referrals and Paediatric Worksharing procedures
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.
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.