International scientific guideline: ICH topic E 14 - Note for guidance on clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

About this guideline

Overseas effective date: 9 Feb 2009

Categories: Clinical efficacy and safety | Cardiovascular system | Arrythmias

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TGA annotations

QT prolongation would be of regulatory concern if either the estimated QT prolongation was >5ms OR the upper bound of the 95% confidence interval was >10ms

For more information see International scientific guidelines adopted in Australia.

Where EU guidelines adopted in Australia include references to EU legislation (including EC Directives and Regulations), the requirements contained in the referenced EU legislation are not applicable to the evaluation of medicines by the TGA.