2023 Volume 40 Issue 4 Pages 442-444
With the enactment of the 21st Century Cures Act in the U.S. and the GCP Renovation proposal of the International Conference on Harmonization of Technical Requirements for the Regulation of Pharmaceuticals (ICH), there has been an active discussion on the utilization of real world data (RWD), which is data obtained in actual medical environments, such as patient registries and medical information by disease, not in experimental environments such as clinical trials (including clinical studies). Real world data (RWD) and Real–world evidence (RWE) generated from the analysis of RWD and RWE are being actively discussed for their utilization under the pharmaceutical affairs system.
In Japan, the Medical Information Database Infrastructure Development Project (MID–NET) and Clinical Innovation Network (CIN) concept, the Conditional Early Approval System for Drugs, and two guidelines by the Ministry of Health, Labor and Welfare and the Pharmaceuticals and Medical Devices Agency (PMDA) regarding the use of registries in regulatory applications are launched.
This symposium will provide an overview of recent trends in the use of RWD/RWE, and will lead to presentations by speakers from industry, government, and academia at this symposium.
