ICH guideline E14/S7B: clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Scientific guideline

The ICH E14 and ICH S7B guidelines concern the multidisciplinary evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products and are complemented by a questions and answers (Q&A) document.

This Q&A document complements the ICH E14 and ICH S7B guidelines to clarify multidisciplinary aspects related to the evaluation of QT/QTc interval prolongation and proarrhytmic potential for non-antiarrhythmic medicinal products. It addresses various aspects addressed in the two guidelines, including: electrocardiogram methodology, study design aspects including choice of positive control and monitoring provisions, use of concentration response-modeling, non-clinical integrated risk assessment, best practice considerations for in vitro and in vivo non-clinical studies.

Of note, this Q&A replaces the previous ICH E14(R3) Q&A document.

Keywords: QT/QTc interval prolongation, proarrhythmic potential, noncardiovascular drugs, thorough QT/QTc study, concentration-response modelling, non-clinical

Current effective version

ICH guideline E14/S7B: clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - questions and answers - Step 5

Adopted Reference Number: EMA/CHMP/ICH/415588/2020 Legal effective date: 27/07/2022

Document history

ICH guideline E14/S7B: clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential - questions and answers - Step 5

Adopted Reference Number: EMA/CHMP/ICH/415588/2020 Legal effective date: 27/07/2022

ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b

Draft: consultation closed Consultation dates: 28/08/2020 to 28/11/2020 Reference Number: EMA/CHMP/ICH/415588/2020

Overview of comments received on ICH guideline E14/S7B on clinical and nonclinical evaluation of QT/QTc interval prolongation and proarrhythmic potential - questions and answers - Step 2b

Reference Number: EMA/658070/2020

ICH guideline E14: the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) - questions and answers - Step 5

Reference Number: EMEA/CHMP/ICH/310133/2008 Legal effective date: 01/05/2012