ICH Project ICH E14/S7B Implementation Working Group: Q&A (Draft) Information Session on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects
April 07, 2026
The ICH E14/S7B Implementation Working Group (IWG) has been working on the 2nd stage Q&A on "Clinical and Non-clinical Evaluation of QT/QTc Interval Prolongation and Potential Proarrhythmic Effects". Based on the general consensus of the IWG on the draft Q&A, we will hold a briefing session on the outline of the draft Q&A.
Unlike the Q&A released in 2022, the 2nd stage Q&A will not be subject to public comment upon agreement of the IWG, considering that there are no significant additions or changes in evaluation methods, etc.
The details of this briefing can be found on the PMDA Website.