The International Council for Harmonisation (ICH) met virtually on 27 May, in place of the face-to-face meetings that were to take place in Vancouver, Canada.

Further to ICH’s commitment for stakeholder engagement with academic clinical researchers and patient representatives...

With ICH commemorating its 30th Anniversary in 2020, ICH is pleased to release a video in which ICH Members and Observers look back at ICH’s evolution...

The ICH S11 Guideline on Nonclinical Safety Testing in Support of Development of Pediatric Medicine reached Step 4 of the ICH Process in April 2020.

Generics (January 2026) [Track version]

Bupropion NL/H/PSUFU/00000461/201812 Date of publication: 06/04/2020 PSUSA/00000461/201812 Date of publication: 17/12/2020

Fragmin (dalteparin sodium) UK/W/0112/pdWS/001 End of procedure: 31/10/2019 Date of publication: 06/04/2020 SI/W/0008/pdWS/001 End of procedure: 20/06/2023 Date of publication: 28/07/2023

The coronavirus (COVID-19) pandemic has prompted an urgent need for a harmonised, standardised approach to coding and reporting the infection as a global health issue.

The ICH Q3C(R8) draft Guideline on Impurities: Guideline for Residual Solvents, revised to include the Permitted Daily Exposure (PDE) levels for 2-Methyltetrahydrofuran,...

The ICH biannual meeting, scheduled to be held in Vancouver in May 2020, is cancelled.