GlobalSubmit 25.3.1 introduces key enhancements for regulatory document submissions, including eCTD 4.0 management for Japan PMDA, improved context group and keyword management, and better document reuse. User experience upgrades feature an updated Contacts page and new support for FDA 4.0 and EU 3.1. The release also resolves several issues for a more efficient experience. For further details, read on.
What’s New in GlobalSubmit
Create and publish eCTD 4.0 submission-units for Japan PMDA (SB-5215)
Benefits | Features |
Access to latest eCTD 4.0 Guidance.
Easy-to-use UI makes transition seamless.
Web-based UI provides anywhere access.
Consult with our SME’s to prepare for the change.
Become an early adopter of the change.
Create Japan eCTD 4.0 applications. | Create and delete an application.
Edit application properties.
Create, publish, and delete a submission-unit.
Edit submission-unit properties. Create, edit, and delete contacts for a submission.
Add files to a submission-unit.
Rename the title of a file.
Delete a single file from a section. View eCTD 4.0 tree. Process and view eCTD 4.0 |
Process and view eCTD 4.0 applications for Japan PMDA (SB-5215)
Benefits | Features |
Process existing Japan eCTD 4.0 applications.
View eCTD 4.0 applications | Load Japan eCTD 4.0 applications.
Remove from DB/Delete applications from Load/Validate.
View Japan eCTD 4.0 applications in Review.
View files in the Preview pane. Show/Hide empty sections |
Manage context groups, keywords, and folders in eCTD 4.0 applications for Japan PMDA (SB-5215)
Benefits | Features |
Easy access to context groups and keyword management tools within the tree.
Use pre-defined keywords or create your own, based on submission needs.
Flexibility in arranging output data via sub-folder creation. | Create a Context Group with a set of keywords.
Use the same keyword definitions across multiple submissions.
Edit/Delete a Context Group. Manage output folders for Context Groups.
Review submission-units with Context Groups. Delete user-created folders. |
Reuse files and documents in eCTD 4.0 for Japan PMDA (SB-5215)
Benefits | Features |
Track the original location of copied files.
Use a different title for a copied file. | Copy/Paste a file for Reuse.
Edit the title of a file for Document Reuse.
Delete a Reused file. |
Add elements to a document in eCTD 4.0 for Japan PMDA (SB-5215)
Benefits | Features |
Use additional metadata in a document. | Add Thumbnail and/or Description.
Add Charset for XPT files. |
Manage, replace, and suspend relationship files for Japan PMDA (SB-5215)
Benefits | Features |
Replace – Submit the latest files in future submission-units.
Replace – Easy-to-use operation to maintain lifecycle for file between submission-units.
Suspend – Mark files no longer relevant to the submission.
Suspend – Easy-to-use operation to indicate a file’s relevancy and maintain lifecycle for a file between submissionunits. | Replace one file with another file.
Replace one file with many files or many files with one file.
Undo a Replace relationship.
Suspend a file in future submission-units.
Undo a Suspend relationship. |
User experience improvements (SB-7637)
Benefits | Features |
An updated Contacts page provides easy access to more information, such as the submission-unit for which a contact was created. | The updated Contacts page displays more information. |
Suspend contact relationship for FDA 4.0 (SB-2853)
Benefits | Features |
Update – Easy-to-use operation to indicate a contact’s relevancy and maintain lifecycle for a file between submission-unit(s). | Modify a contact in a future submission-unit(s).
Undo an Update relationship. |
Choose center for cross-reference applications for FDA 4.0 (SB-5468)
Benefits | Features |
Cross-reference applications across different FDA centers. | Select a center for each cross-reference application. |
Ability to support EU 3.1 (SB-8565)
Benefits | Features |
This update enables to submit as per the latest guidance.
Enables to see the new values as per the updated guidance. | Select and publish the latest country and language codes.
Select the latest Regulatory Activity and Sequence types.
Ability to view tree with latest values. |
Update support of valid values to version 6 (SB-8474)
Benefits | Features |
Availability of latest tags in study tagging files. | Use the latest valid values and include them in the study tagging file output.
View the latest valid values and associated files within the tree. |
Support Canada Validation v5.3(SB-8413)
Benefits | Features |
Availability of latest error codes in reports. | Use the latest validation codes and get up-to-date error codes and criteria. |
Issues Corrected in GlobalSubmit
Issue Summary | Correction |
GlobalSubmit Publish (browser) Available action buttons for a file were not updated after the replaced relationship was removed. (SB-7715) | The action buttons are now properly made available. |
GlobalSubmit Publish (browser) Incorrect Delete Submission-Unit message was displayed for the last submission-unit if its tree was expanded. (SB-5538) | The message now states that the submission-unit and the application will be deleted since it is the last one. |
GlobalSubmit Publish (desktop) Incorrect folder structure getting outputted for some sections. (SB8509,8610) | The folders 1.2,1.3.1, and 1.3.2 now output a country/language folder as per the recommendations provided by the agency. |
Certara® Contact Information
Technical support Consult the software documentation to address questions Certara GlobalSubmit User Guide.
If further assistance is needed, contact Certara Support through e-mail or our support portal.
E-mail: support@certara.com
For the most efficient service, e-mail a complete description of the problem, including copies of the input data