Electronic Submission and Utilization of CDISC Standardized Clinical Study Data in Japan

Abstract

In Japan, the submission of subject-level electronic clinical study data for new drug applications began on October 1, 2016 and included a transitional period that expired on March 31, 2020. Currently, most new drug applications (NDAs) require the submission of electronic clinical study data, which are considered important to provide information about a drug at the review and are required by the Pharmaceuticals and Medical Devices Agency (PMDA). Standardization of submitted electronic clinical study data is essential to efficient review, using data analyses for applications of various drugs submitted by multiple companies with limited review time and human resources. For most clinical trials, the PMDA requires study data to be submitted in accordance with CDISC standards.This paper provides an overview of the advanced review with electronic data project and the current state of electronic data submission in Japan, as well as in terms of future expectations for the data standards, as based upon the experiences of receiving and utilizing CDISC-compliant clinical study data in the PMDA.