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

Abstract

In Japan, the submission of subject-level electronicclinical study data for new drug applications began on October 1, 2016, with a transitionalperiod. The transitional period expired on March 31, 2020, and currently, mostnew drug applications (NDAs) require the submission of electronic clinicalstudy data, which are considered important to provide information about a drugat the review and are required by the Pharmaceuticals and Medical DevicesAgency (PMDA). Standardization of submitted electronic clinical study datais essential to review using data analyses for applications of various drugssubmitted by multiple companies with limited review time and human resources.For most clinical trials and analyses, the PMDA requires clinical trial data tobe submitted in accordance with CDISC standards.This paper provides an overview of the advanced review with electronicdata projectand the current state of electronic data submission in Japan, as well asin terms of future expectations for the data standards, as based upon theexperiences of receiving and utilizing CDISC-compliant clinical study data inthe PMDA.