Genotoxicity Guidelines Recommended by International Conference of Harmonization (ICH)

Genotoxicity tests are designed to detect the genetic damage by various mechanisms. Several guidelines have provided various tests to be conducted for testing the genotoxicity and each of the regulatory agencies around the world have developed their own requirements for mutagenicity, without realizing that the products developed or registered in one country are also going to be registered and marketed around the world. The ICH guideline of genotoxicity helps to optimize the standard battery for genetic toxicology and to provide guidance on interpretation of results. These suggested standard set of tests does not imply that other genotoxicity tests are inadequate or inappropriate, but they help in improving risk characterization for carcinogenic effects that have their basis in changes in the genetic material.