Cardiac safety of drugs is the most common cause of drug withdrawal from the market or delay in or denial of regulatory approval for marketing.
In October 2005, concepts on how cardiac safety of a new drug should be determined during its clinical development were formalized. The ICH E14 represents a significant landmark. It is the first globally harmonized regulatory guidance for assessment of cardiac safety during clinical drug development. This guidance has been fully accepted by the regulatory bodies of the three ICH regions—European Union, Japan, and the United States.
The purpose of the governance section is to provide a summary of this guidance with supportive documentation and results of 3rd party analysis of the adoption and respective metrics.
ERT
