ABSTRACT
An adverse drug reaction report system has played an important role to obtain safety information and to consider safety measures in Japan. However, there are some limitations in the system; for example, the number of prescribed patients cannot be found; it is difficult to differentiate between disease symptoms and adverse drug reactions; and no information can be grasped without a report from a health care professional. Therefore, Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) started an electronic medical information networking project since FY2011 in order to develop a new method to consider safety measures. In this project, MHLW/PMDA plan to establish medical information databases in 10 hospitals and a data analysis system in PMDA. The first database prepared by the University of Tokyo Hospital and the data analysis system in PMDA are almost available, and discussions for rules to utilize electronic medical records are ongoing. After the development of the rules, MHLW/PMDA will experimentally run the system in PMDA, support accumulating data from electronic medical records in the 10 hospitals and create analytical methods where the databases in these hospitals are leveraged. (Jpn J Pharmacoepidemiol 2013；18(1)：15-21)