Drug Evaluation Committee Notice of Publication of Guidance for Creating XML Files for Notification of Clinical Trials (Version 3)
Electronic Standard for Medical Information Expert Committee
March 2019
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 3 is continuing its efforts to promote online application and notification procedures for pharmaceuticals and other products.
Regarding clinical trial notification, we published the second edition of the revised "Guide for Creating XML Files for Clinical Trial Notification" (hereinafter referred to as the "Guide") in November 2013, and furthermore, in October 2017, we have responded by publishing an old/new comparison table reflecting new notifications and actual operational conditions after consultation with the PMDA.
And now, in March 2019, we are pleased to announce the release of the third edition of this guidance. In this third edition, we have updated the latest notifications and descriptions of operational realities, and decided to provide them in electronic format. In line with this change, the structure has been modified to facilitate electronic use.
We hope that you will make use of this guide when creating and submitting XML files of clinical trial notifications in the future.
About Attachment 2 and Attachment 3
Please download the compressed file in zip format and unzip it.