v3.2.0

In this version, we added the ability to export an eCTD v3.2.2 submission as HTML. Using the same steps as the eCTD v4.0 HTML export added in 3.1.1, you can take submissions stored in cloud storage or in an album and package them into a form you can browse with nothing but a web browser.

We also fixed issues with reading eCTD v3.2.2 Sequence numbers and with the display of the eCTD v4.0 Submission tab.

New Features

You can now export an eCTD v3.2.2 submission as HTML

From the menu at the top right of the v3.2.2 viewing window, choose “Export HTML”, specify the destination folder, and start. Progress is shown while the export runs, and you can cancel partway through. When it finishes, “Open Folder” takes you to the destination.

What is exported

A folder named <Application ID>_<date and time> is created in the destination, containing the following set.

File / Folder	Contents
index.html	A list of all Sequences and a summary of file counts
tree-<Sequence number>.html	The CTD tree for that Sequence
files/	The documents referenced from the tree, index.xml, and the region-specific XML

The export covers not only the selected Sequence but every Sequence that has been loaded. index.xml and the region-specific XML are placed at the same locations they occupy inside the submission.

What you can do in the exported HTML

• Switch Sequences from the fixed bar at the top of the page
• Filter the tree by entering a keyword
• Expand all / collapse all the tree
• Lifecycle operations (new / replace / append / delete) are shown as badges on the tree
• From the Sequence list in index.html, you can open the index.xml and the region-specific XML of each Sequence

Key Benefits

• You can ask colleagues and partners who do not have Power Viewer installed to review a v3.2.2 submission
• Submissions kept in cloud storage or in an album can be taken out in a locally viewable form with access control still applied
• Documents are included with the same folder structure as the viewing screen, so cross-references between submission files written inside PDFs and XML (relative links) continue to work

Requirements

• This feature is available on the Business plan only. On the Free plan, the button is disabled and the reason is shown
• Under group policy, “eCTD HTML Export” can restrict this to Administrators only (the default is all users). It is the same setting as for v4.0, so there is no need to recreate your existing group policy file (.pvaf)
• Only applications for which you have document download permission are covered

Please Note

• Because the export covers all Sequences combined, the output can reach several gigabytes. Please check the free space at the destination. The confirmation screen shown before starting displays the number of Sequences and files to be exported
• Documents that could not be included due to access restrictions or retrieval failures remain in the tree without a link, with the reason shown next to them. If even one is missing, a notice that the export is incomplete appears at the top of index.html. Please do not treat a folder in this state as a complete copy of the submission
• STF, define.xml, and the region-specific XML are included as the submission’s own XML files. The viewing screen formats them for display, so they will look different

Bug Fixes

Fixed an issue where all Sequence numbers became 0000 for some US submissions

Because of a difference in how us-regional.xml is written, there were submissions whose Sequence number and Application number could not be read, causing every Sequence to be registered as 0000. Both formats are now supported.

We also stopped registering a default value when the region-specific XML cannot be read, so that “no XML” and “XML present but unreadable” are now distinguished.

Fixed an issue where the application shut down when certain folder names were present

When opening a folder directly, a single folder with a name that cannot be treated as a Sequence number — such as 000 — caused the application to shut down. This has been fixed.

Fixed an issue where multiple Submissions in the same Sequence were mixed up (eCTD v4.0)

For submissions where one Sequence contains multiple Submissions, the CodeSet / ContactParty / Review on the Submission tab all showed the contents of the first Submission, and the contents of the other Submissions were not shown. This has been fixed for all regions: Japan, the United States, Europe, and Other.

Fixed an issue where the Add SubmissionUnit dialog became unresponsive

In the Add SubmissionUnit dialog, a failure while moving to the next step left the dialog in an unusable state where even Cancel did not work. A message is now shown when it fails, and you can continue working.

Other

• This version also includes service stability improvements and internal quality improvements