The 25th Japanese Clinical Pharmacology Society Annual Meeting, held on September 17-18, 2004 in Shizuoka, featured a symposium on safety (Symposium 2) titled "Toxicogenomics: Current Status and Application in Clinical Pharmacology." Toxicogenomics aims to establish a new method for evaluating toxicity by understanding the interaction between environmental chemicals and drugs at the genetic level, using human genome information and new genomic analysis methods. In Japan, the "Pioneering Advanced Medical Technology Research Project (Toxicogenomics Field)" was initiated in 2002 by the Ministry of Health, Labour and Welfare, involving the National Institute of Pharmaceutical and Food Sanitation (NIS) and 17 pharmaceutical companies. This project aims to develop a more reliable toxicity evaluation method based on gene expression data obtained from DNA chips. The database is expected to be used for early-stage safety prediction and mechanism elucidation of adverse reactions. The project was completed in 2006, with the database to be released three years later. Another project, the "Comprehensive Evaluation and Management Program for Chemical Substances," started in 2001 by the Ministry of Economy, Trade and Industry and NEDO, includes a project to develop a high-precision and simple hazard evaluation system. This project aims to identify differences between carcinogens and non-carcinogens by analyzing gene expression changes in liver cells of rats. The project has achieved a 96% prediction accuracy for carcinogenicity. While government-led toxicogenomics research is gaining attention, pharmaceutical companies are also conducting their own toxicogenomics research for early screening of drug candidates and understanding of toxicity mechanisms. To further advance toxicogenomics, research using human tissues is necessary. The "Pioneering Advanced Medical Technology Research Project" has laid the foundation for toxicogenomics research using human tissues in Japan. It was found that genetic variation in gene expression is about 0.01%. Thus, toxicogenomics research is still in its early stages, but it is expected to develop more reliable safety evaluation methods for drugs and chemicals in the near future.The 25th Japanese Clinical Pharmacology Society Annual Meeting, held on September 17-18, 2004 in Shizuoka, featured a symposium on safety (Symposium 2) titled "Toxicogenomics: Current Status and Application in Clinical Pharmacology." Toxicogenomics aims to establish a new method for evaluating toxicity by understanding the interaction between environmental chemicals and drugs at the genetic level, using human genome information and new genomic analysis methods. In Japan, the "Pioneering Advanced Medical Technology Research Project (Toxicogenomics Field)" was initiated in 2002 by the Ministry of Health, Labour and Welfare, involving the National Institute of Pharmaceutical and Food Sanitation (NIS) and 17 pharmaceutical companies. This project aims to develop a more reliable toxicity evaluation method based on gene expression data obtained from DNA chips. The database is expected to be used for early-stage safety prediction and mechanism elucidation of adverse reactions. The project was completed in 2006, with the database to be released three years later. Another project, the "Comprehensive Evaluation and Management Program for Chemical Substances," started in 2001 by the Ministry of Economy, Trade and Industry and NEDO, includes a project to develop a high-precision and simple hazard evaluation system. This project aims to identify differences between carcinogens and non-carcinogens by analyzing gene expression changes in liver cells of rats. The project has achieved a 96% prediction accuracy for carcinogenicity. While government-led toxicogenomics research is gaining attention, pharmaceutical companies are also conducting their own toxicogenomics research for early screening of drug candidates and understanding of toxicity mechanisms. To further advance toxicogenomics, research using human tissues is necessary. The "Pioneering Advanced Medical Technology Research Project" has laid the foundation for toxicogenomics research using human tissues in Japan. It was found that genetic variation in gene expression is about 0.01%. Thus, toxicogenomics research is still in its early stages, but it is expected to develop more reliable safety evaluation methods for drugs and chemicals in the near future.