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ICH topic E 14 -The clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs

We have adopted this International Scientific Guideline – ICH E14; CHMP/ICH/2/04

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About this guideline

Overseas effective date: November 2005

Note: This should be read together with ICH guideline E14 - the clinical evaluation of QT/QTc interval prolongation and proarrhythmic potential for non-antiarrhythmic drugs (R3) – questions and answers (ICH14 Q&As; EMA/CHMP/ICH/310133/2008).

Categories: ICH | Efficacy

Clinical efficacy and safety | Cardiovascular system | Arrythmias

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 >10msude 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.

  • 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.
  • All documents and other content published by the European Medicines Agency (EMA) on this website are under the copyright and other intellectual property rights ownership of the EMA. Please refer to Legal notice | European Medicines Agency for further information.

For more information see International scientific guidelines adopted in Australia.

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