Drug Evaluation Committee Notice of Publication of the First Provisional Edition of Guidance for Creating Electronic Files of Attachment Information for Ethical Drugs - XML format
Electronic Information Subcommittee
May 2019
Task Force 2-2 of the Electronic Information Subcommittee of the Drug Evaluation Committee of the Japan Pharmaceutical Manufacturers Association (JPMA) is focusing on the study of electronic format for accompanying document of ethical drugs, etc.
The new description guideline for accompanying document came into effect on April 1, 2019, and the electronic file used together with PDF to provide information on accompanying document The format of the electronic file to be used in conjunction with the provision of information on the attached document along with PDF is now XML format. In response to this, we have prepared and published a guide to explain the points to keep in mind in order to smoothly create the XML file required for notification of the attached document in accordance with the new guidelines. At this time, this is a "provisional version 1" in order to quickly inform the industry as a whole of the minimum rules that must be followed. We will revise the document in the future, based on the information collected from case studies of the attached documents of the version corresponding to the new description guidelines and materials prepared by PMDA.
We hope that you will make use of this guide when creating XML files of accompanying documents for ethical drugs in the future.
XML Creation Guide_Version 1 (732KB)
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