Drug Evaluation Committee Notice of Publication of XML File Creation Guide for Notification of Clinical Trials (4th Edition)

Electronic Information Subcommittee

February 2021

The Japan Pharmaceutical Manufacturers Association (JPMA) Drug Evaluation Committee Electronic Information Subcommittee Task Force 3 has been continuously working on the online application and notification procedures for pharmaceuticals and medical devices.
Recently, the "Ministerial Ordinance Concerning the Establishment, etc. of Relevant Ministerial Ordinances Accompanying the Enforcement of the Act for Partial Revision of the Act on Quality, Efficacy and Safety Assurance of Pharmaceuticals, Medical Devices and Other Related Matters" (Ministry of Health, Labor and Welfare Ordinance No. 155, 2020) came into effect and the "Handling of Notification, etc. of a Clinical Trial Plan for a Drug by a Person Who Wishes to Request a Clinical Trial" (Ministry of Health, Labor and Welfare Ordinance No. 165, 2020) was enacted. (August 31, 2020, Pharmaceutical Affairs Bureau Notification No. 0831-10).
In accordance with the content of the ministerial ordinance and the notification, we have revised the old manual for the creation of XML files for the Notification of Clinical Trials in the new format, and have published the fourth edition.
We hope you will find this guide useful when creating and submitting the XML file of the Notification of Clinical Trial.

If you wish to submit a clinical trial notification according to the previous format, please continue to refer to the third edition published in March 2019.

Notice of Publication of Guidance for Creating XML Files for Notification of Clinical Trials (Version 3)

Attachment 2 and Attachment 3: The files are downloaded in compressed zip format.

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