Issue Date: October 30, 2026
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Efficacy, ICH-Safety
Status: Final
E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential–Questions and Answers (R1): Guidance for Industry
This question-and-answer (Q&A) document is intended to clarify key issues to facilitate implementation of the ICH guidances for industry E14 “Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs” (October 2005) and S7B “Nonclinical Evaluation of the Potential for Delayed Ventricular Repolarization (QT Interval Prolongation) by Human Pharmaceuticals” (October 2005). The revised Q&A document includes updates to Questions 5.1, 6.1, and 6.3 for E14, as well as revised and new questions for Sections 1 and 3 of S7B.
Download the Guidance Document
