ICH Project Genotoxicity Studies Q&A 2014 (revised edition)
The Genotoxicity Study Q&A 2014 (Revised Version) was prepared by the Basic Research Subcommittee of the Drug Evaluation Committee. The Basic Research Subcommittee has prepared "Genotoxicity Studies Q&A 2014 (Revised Edition)" to explain various issues related to the implementation of the studies, focusing on the revised guidelines for genotoxicity studies of pharmaceutical products whenever they are revised or issued in Japan. The previous editions in 1992 and 2000 were published, but for various reasons, we decided not to publish them this time. However, since there are many requests for this revised version of the Q&A from companies other than the Pharmaceutical Manufacturers Association of Japan (PMAJ) and contract research organizations for non-clinical studies, we have decided to make it available on the PMAJ website for wide public use. This is the first revision of the MHLW's guidelines on genotoxicity testing in 13 years, and has been substantially updated to incorporate changes in thinking on genotoxicity testing and the development of new testing methods during this period. The Q&As published this time are limited to those related to items that have been changed or added in the revised guideline and those for which it is necessary to update information. Therefore, please also refer to the previously published "Genotoxicity Studies Q&A" (Scientist, Tokyo, 2000) for issues you may face in conducting routine studies.
Unauthorized copying or reproduction of the attached materials is strictly prohibited.