NEWS Date: Apr 16, 2021
Seoul, Korea- As of April 16th, the Korea Ministry of Food and Drug Safety has issued a revised guideline on the non-clinical evaluation of the potential for delayed ventricular repolarization by human pharmaceuticals.
The revised guideline mainly discusses the cardiac multi-ion channel assay method and the iPSC-derived cardiomyocyte action potential assessment method.
This update is in preparation of upcoming revision for International Council on Harmonization (ICH) guideline S7B, which covers cardiac arrhythmia related safety pharmacology.
The ICH is planning to implement the aforementioned test methods to complement the hERG assay by early 2022.
The revision is led by the Health and Environmental Sciences Institute (HESI), with several authorities and organizations of related expertise including NEXEL Co., Ltd. collaborating to provide validation studies for the test methods.