18 December 2015

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).

Since reaching Step 4 and publication within the ICH regions, experiences by all parties with the implementation of the E14 Guideline have resulted in the need for some clarification. The Questions and Answers developed by the E14 Implementation Working Group (IWG) are intended to facilitate the implementation of the E14 Guideline by clarifying key issues. In this document, the E14 Q&A on Concentration-Response Modelling (# 5.1) was revised to generate harmonised guidance on how concentration response modelling could be used for regulatory decision making.

The E14 Q&As (R3) document is available for download under the Efficacy Guideline page on the ICH website.