A Brief History of Proarrhythmic Cardiac Safety

1997 The European Medicines Evaluation Agency s (EMEA s) Committee of Proprietary Medicinal Products released a Points to Consider document on the assessment of the potential for QT interval prolongation by noncardiovascular medicinal products (EMEA 1997) 

1999 The FDA set up a working group and generated internal documents on QT assessment 

2003 A joint Health Canada/FDA Concept Paper was circulated and the ICH process initiated 

2005 ICH issued guidelines S7B and E14, which were adopted in Europe and the USA in 2005 and in Canada in 2006 

2006 FDA established its QT interdisciplinary review team (IRT), which reviews protocols and study reports for thorough QT/QTc studies and advises review divisions accordingly 

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