Asuntos regulatorios farmacéuticos: acceso abierto

Systems, regulations and use of real-world data, including healthcare databases and disease registries, in drug development and post-approval evidence generation in Japan.

Abstract

Makoto Nagaoka*, Yuki Tajima, Tomoko Kato

In Japan, the system and regulations regarding the utilization of 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) have been established ^to utilize disease registries, 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 the drug usage outcome survey (a kind of product registry), but there are more and more cases of utilizing healthcare big data, such as medical information databases in hospitals and health insurance databases. It is expected that the utilization of RWD in clinical development will become more active after the establishment of guidelines and the pilot implementation of the regulatory system in the future.