Practical Utilization Methods of Investigations Using Medical Information Databases for Post-Marketing Safety Measures

Abstract

Medical information databases, which systematically accumulate electronic medical information into databases, have been promoted for use in postmarketing safety activities since the environment for their use was partially developing in 2017. The Ministry of Health, Labour, and Welfare (MHLW) issued a notification on the basic approach to using such databases for postmarketing safety surveillance as one of such promotional activities. Full-scale operation of MID-NET^® has started and multiple databases have become available for use for more than 6 years since the issuance of the notification, but such real-world data has remained insufficiently utilized by pharmaceutical companies for their postmarketing safety activities (i. e., enhancement of package insert information, such as precautions for use). Some assert that one of the causes is ambiguity about whether and how evidence obtained from the use of such real-world data can be reflected in package insert material. Under such circumstances, MHLW and Pharmaceuticals and the Medical Devices Agency have recently discussed how to appropriately use the real-world data evidence to enhance package insert information and devised a scheme to practically use the evidence in order to promote the utilization of medical information databases for postmarketing safety measures. Herein, we present the outline of this discussion, along with the related notifications issued in February 2023, as the first-round result of the discussion.