Pharmaceutical Regulatory Affairs: Open Access

Systems, Regulations and Utilization of Real-World Data Including Healthcare Database and Disease Registry in Drug Development and Post-Approval Evidence Generation in Japan

Abstract

Makoto Nagaoka*, Yuki Tajima and Tomoko Kato

In Japan, the system and regulations regarding the utilization of the big data in healthcare or real-world data (RWD) for drug development are being established. A large-scale database of electronic medical information for post-marketing pharmacovigilance, the Medical Information Database Network (MID-NET^®), and the Clinical Innovation Network (CIN) for utilizing disease registries have been created, and guidelines have been issued in sequence from those related to post-marketing database surveys. At present, the utilization of RWD in pharmacovigilance is still largely based on drug use results survey (a kind of product registry), but there are increasing cases of utilizing healthcare big data, such as medical information databases in hospitals and health insurance databases. It is expected that utilization of RWD in clinical development will become more active after the establishment of guidelines and the pilot run of the regulatory system in the future.