2020 Volume 10 Issue 3 Pages 187-193
PMDA started accepting electronic submission of study data for new drug application in October 2016 and the transitional period for submitting electronic study data was ended on March 31, 2020. PMDA had taken necessary measures such as revisions to notification, toward the end of the transitional period. PMDA’s consultation service related to the submission of electronic study data has been conducted since May 15, 2015. The number of consultations reached 387 by March 31, 2020 and tends to increase each year. After the start of submission of electronic study data, 116 electronic study data were submitted by March 31, 2020, and PMDA has been using the electronic study data submitted in the approval review of new drugs. In addition, PMDA is considering such as analysis of integration of cross-products information of accumulated electronic study data. After the transitional period ends, if necessary, PMDA will take measures such as revisions to notification, based on the submission status of the electronic study data.
