Tracking XML™ is a self-contained, stand-alone Windows® desktop application that lets you create and manage the required Tracking.XML file for MRP (Mutual Recognition Procedure) and DCP (Decentralized Procedure) procedures, based on eCTD applications in the European Union region. This application creates the tracking XML file using the DTD and specifications published by the EMEA.
Tracking XML™ can be used in the following scenarios:
A brand new application with an initial submission
Create the “tracking.xml” file for the initial submission in a new eCTD application.
An existing application with one or more submissions already submitted to the agency
Create the “tracking.xml” file for the current (or a new) submission in an existing eCTD application.
The tracking.xml file contains information from all submissions in a given application. Even though there is no need to update previously submitted information, in order to create the “tracking.xml” file for the current submission, the application requires information from all previous submissions.
Submissions submitted to the agency with “Tracking.PDF” files
In this case, the Tracking XML™ application prompts you to verify and confirm information from each sequence. Since information cannot be extracted from the PDF file, the application will read the necessary information from the regional XML backbone files and prompt you for verification and confirmation. You must save this information for each submission.
The information saved is used for the current submission and no changes are made to previously submitted submissions.
Submissions submitted to agency with “Tracking.XML” files
The Tracking XML™ application will automatically extract the necessary information from the previous submission. It is not necessary to recreate the information from submissions that werepreviously submitted.
This option assumes the “tracking.xml” file was included in the previous submission, is valid XML, and is in compliance with DTD and specifications published by the EMEA.
Tracking XML is Required in all eCTD Submissions in the European Union.
System Requirements
Operating System
- Microsoft® Windows® 2000/XP/Vista/Windows7
- Microsoft® .NET Framework 2.0 or later
- Microsoft® Internet Explorer 6.0 or later (or other compatible web browsing applications such as Firefox, Chrome, and Safari)
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