Electronic Common Technical Document Implementation in Japan

Abstract

The main missions of the Pharmaceuticals and Medical Devices Agency (PMDA) are the review of drug applications and also being in charge of the electronic common technical document (eCTD) regulations in the review process. However, we believe that we should consider enhancing eCTD implementation with other activities in electronic standardization of clinical trials. With this sense, the Ministry of Health, Labor and Welfare (MHLW) and PMDA are cooperating to enhance eCTD and e-clinical trials in Japan. This article introduces eCTD implementation in Japan, and also our concept for enhancing eCTD submissions in view of the Japanese government initiative for supporting the development of new drugs by the electronic standardization of clinical trials. PMDA is keen to have eCTD submissions and hopes these activities for eCTD will enhance the understanding of our concepts and support the activities of developing drugs in Japan.