ICH Project ICH E14/S7B Implementation Working Group: Briefing Session on the Draft Q&A Regarding “Clinical and Nonclinical Evaluation of QT/QTc Prolongation and Potential for Arrhythmogenicity”
April 7, 2026
The ICH E14/S7B Implementation Working Group (IWG) has been continuing its deliberations toward the development of the second-stage Q&A regarding “Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Potential for Arrhythmogenicity.”Now that the IWG has reached general consensus on the draft Q&A, we will hold a briefing session to present an overview of the draft Q&A.
Please note that, unlike the Q&A published in 2022, the second-stage Q&A does not include significant additions or changes to evaluation methods or other aspects; therefore, in accordance with the IWG’s consensus, we will not solicit public comments.
Details regarding this briefing session are available on the PMDA website.