Drug Evaluation Committee Notice of Publication of Guidance for Creating XML Files for Notification of Clinical Trials (Version 3)
Electronic Information Subcommittee
March 2019
Task Force 3 of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) is continuing its efforts to promote online application and notification procedures for pharmaceuticals and other products.
In November 2013, we published the second edition of the revised "Guide for Creating XML Files for Notification of Clinical Trials" (hereinafter referred to as the "Guide"), and in October 2017, we published an old/new comparison table reflecting new notifications and actual operational conditions after consulting 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.
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