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    ICH updates: E14 consultation, Health Canada implements M9 guideline

    The International Council for Harmonisation (ICH) on Thursday announced its E14/S7B draft questions and answers guideline on clinical and nonclinical evaluation of QT/QTc interval and proarrhythmic potential has reached Step 2b of the ICH process.   On Friday, the European Medicines Agency (EMA) opened a three-month public consultation to gather feedback on the document. ICH will also be hosting a two-day public meeting to provide a high-level overview of the docum...
  • ICH Releases Update for E14 Guideline on Clinical Evaluation of Non-Antiarrhythmic Drugs

    The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has released an updated version of its Efficacy (E) 14 Guideline, providing four new pieces of insight on the clinical evaluation of non-antiarrhythmic drugs. ICH's Q&A document for E14 - The Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs was originally released under Step 4 o...