Abstract： The rasH2-Tg bioassay is a wildly used transgenic alternative model in short-term carcinogenicity test,which is sensitive to gene-positive or negative carcinogens.No details have been found about experimental requirements for the model in relevant guidelines at home and abroad.This review summarized the information of rasH2-Tg test batteries from 51 new drug application reviews evaluated by FDA/CDER from 2013 to 2022,and described the key points in the trial design combined with practical experience.The review aims to support the development of carcinogenicity trials of transgenic alternative models for the use of new drugs in China.