The revised version of the ICH E14 Questions & Answers on The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drug reached Step 4 of the ICH Process in December 2015 and now enters the implementation period (Step 5).
The Membership and Observership Application Process is now available on the ICH website.
The PSUR Repository bulletin has been updated
As part of increasing the international outreach and inclusiveness of ICH, one of the first points of business was to review the application process for new Members and Observers. More information about the procedure, including application forms, will be published on the ICH website.
List of documents published on CMDh website (July 2025)(to be used to locate documents on the CMDh website)
A number of defects have been reported in the release v.1.19 of the eAFs. The EMA is working hard to fix these issues as soon as possible and a hotfix release will be deployed as soon as possible. Meanwhile if you are experiencing issues with any of the electronic application forms v.1.19 as published on [...]
A webinar on the eAFs (initial, variation, renewal) for Human and Veterinary procedures will be held on 01 December 2015 from 13.00 to 14.30 UK time. This webinar is dedicated to Industry. This session will not demonstrate how to fill in the forms but will rather provide information where to find relevant documents and will [...]
Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (October 2024)
The International Council for Harmonisation (ICH), formerly the International Conference on Harmonisation (ICH) held the inaugural meetings of its new Assembly [and Management Committee] on 23 October 2015.
Concerned Member State's Comments on Lead Member State's Preliminary assessment report (April 2025) [Track version]