Drug Evaluation Committee Guidance for Creating Electronic Files of Attachment Information of Ethical Drugs - XML format - Notice of Publication of the First Provisional Edition
Electronic Standard for Medical Information Expert Committee
May 2019
Japan Pharmaceutical Manufacturers Association Drug Evaluation Committee Electronic Standard for Medical Information Expert CommitteeTask Force 2-2 is focusing on the study of electronic format for accompanying documents of ethical drugs, etc.
The new description guideline for accompanying documents came into effect on April 1, 2019, and the format of electronic files to be used together with PDF to provide information on accompanying documents is XML The format of the electronic file to be used in conjunction with the provision of attached document information along with PDF is now XML format. In response to this, we have prepared and published a guidebook to Explanation of points to keep in mind in order to smoothly create the XML file required for notification of the attached document in the new format. 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.