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ICH has recently published newly developed training materials for four ICH harmonised guidelines, a two-guideline Q&A, and the principles and concepts governing a group of five ICH Quality Guidelines.
ICH has published the updated ICH E14/S7B Questions & Answers (R1) to provide clarifications related to the clinical and nonclinical assessment of QT/QTc prolongation and proarrhythmic risk.
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.
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: the Implementation Guide Package, the Controlled Vocabulary Package and the Q&A document.
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.
The ICH Assembly met in person on 2–3 June 2026 in Rio de Janeiro, Brazil for its biannual meeting, preceded by meetings of the ICH Management Committee and the MedDRA Steering Committee.
The Assembly of the International Council for Harmonisation (ICH) met in person on 2-3 June in Rio de Janeiro, in parallel with meetings of 12 Working Groups and preceded by meetings of the ICH Management Committee (MC) and the MedDRA Steering Committee (SC).