Plan Library: Working with Plans #
The Plan Library in DnXT Publisher is a dedicated workspace for creating and managing submission plans — strategic coordination tools that help regulatory affairs teams organize multi-region submissions, assign documents across regions, and track planning milestones. While the Dossier Library manages actual eCTD submissions, the Plan Library focuses on the planning phase that precedes and guides the authoring process. This guide covers the full Plan Library interface, including creating plans, managing sub-plans, and navigating between plans and their associated dossiers.
What Are Plans? #
A plan in Publisher represents a strategic submission roadmap. Plans are used to coordinate regulatory submissions across multiple regions, products, or time periods. They serve several purposes:
- Multi-region coordination — Plan which documents will be submitted to which regions, identify shared content, and manage region-specific requirements.
- Timeline management — Set target dates for each regional submission and track progress against milestones.
- Resource allocation — Identify which team members are responsible for which components of the submission strategy.
- Document mapping — Map source documents to their target locations across multiple regional dossiers.
Plans vs. Dossiers #
| Aspect | Plan | Dossier |
|---|---|---|
| Purpose | Strategic planning and coordination | Actual eCTD submission authoring |
| Scope | Can span multiple regions | Single region |
| Content | Planning data, timelines, document mapping | Actual documents and eCTD structure |
| Output | Guides dossier creation | Produces eCTD submission packages |
Navigating to the Plan Library #
Click Plan Library in the left navigation panel from any screen in Publisher. The Plan Library opens showing the All Plans tab by default.
Plan Library Tabs #
The Plan Library has six tabs, mirroring the structure of the Dossier Library:
All Plans (Default) #
Displays every plan you have access to. Plans are shown as tiles or list rows depending on your view mode preference. Each plan card shows the plan name, associated product, target regions, and key dates.
All SubPlans #
Provides a flat view of all sub-plans across all plans. Sub-plans are region-specific components within a broader plan. This tab is useful for finding a specific regional sub-plan without first navigating to its parent plan.
Recently Viewed Plans #
Shows plans you have opened recently, ordered by most recent access. This is the fastest way to return to a plan you were working on.
Recently Viewed SubPlans #
Shows recently accessed sub-plans, ordered by most recent access.
Favorites #
Shows plans and sub-plans you have marked as favorites for quick access.
Regulatory Activity #
Shows regulatory milestones and activity logs associated with your plans, such as submission target date changes, region additions, and approval status updates.
Plan Library Toolbar #
The toolbar provides the following controls:
| Control | Description |
|---|---|
| Create Plan | Opens the plan creation form to create a new submission plan. |
| Delete | Deletes the selected plan(s) after confirmation. |
| Filter | Multi-criteria filter dropdowns for narrowing by region, product, status, date range. |
| Save Filter | Saves the current filter combination as a named filter. |
| Tile/List Toggle | Switches between tile view and list view. |
Creating a New Plan #
To create a new submission plan:
- Click the Create Plan button in the Plan Library toolbar.
- Enter the Plan Name — a descriptive name for the plan (for example, “Product X Global NDA Submission Plan 2026”).
- Select the Product — the pharmaceutical product the plan covers.
- Select the Target Regions — choose one or more regions that the plan will cover. For each region, a sub-plan will be created.
- Set Target Dates — optionally set target submission dates for each region.
- Add Planning Notes — optionally add notes about the plan strategy.
- Click Create to generate the plan.
Publisher creates the plan with sub-plans for each selected region. Each sub-plan contains a region-specific TOC structure that mirrors the eCTD requirements for that region.
Understanding Sub-Plans #
A sub-plan is a region-specific component within a plan. If you create a plan covering US, EU, and JP, three sub-plans are generated automatically — one for each region. Each sub-plan has its own TOC structure, document assignments, and planning attributes.
Sub-plans can be viewed in the All SubPlans tab or by opening the parent plan and navigating to the regional view in the Plan TOC Editor.
Opening Plans #
Double-click any plan tile or list row to open it in the Plan TOC Editor. This is a specialized editor designed for plan-level work, with features like the regional planner spreadsheet and multi-tab region management. For details on the Plan TOC Editor, see Plan TOC and Submission Planning.
Managing Plans #
Editing Plan Details #
Click a plan (single click) in the Plan Library to open its details in a sub-panel. You can edit the plan name, add or remove target regions, update planning notes, and modify target dates.
Deleting a Plan #
Select one or more plans and click Delete in the toolbar. Confirm the deletion in the dialog. Deleting a plan also deletes all its sub-plans.
Adding a Plan to Favorites #
Right-click a plan and select Add to Favorites, or use the context menu. Favorited plans appear in the Favorites tab for quick access.
Filtering and Searching Plans #
Use the search bar to find plans by name, product, or region keyword. Use the filter dropdowns to narrow by specific criteria. You can save frequently used filter combinations as named filters using the Save Filter button.
Frequently Asked Questions #
What is the relationship between a plan and a dossier? #
A plan is a strategic coordination tool that guides dossier creation. You can use a plan to organize your submission strategy, then create dossiers based on the plan. The plan and dossier remain linked, allowing you to track execution against the plan.
Can I create a plan for a single region? #
Yes. While plans are most powerful for multi-region coordination, you can create a plan for a single region to take advantage of the planning spreadsheet and timeline tracking features.
Can I add regions to a plan after creation? #
Yes. Open the plan details and add new target regions. A new sub-plan will be created for each added region.
How do I convert a plan into actual dossiers? #
From the Plan TOC Editor, you can initiate dossier creation based on the plan’s regional sub-plans. This creates dossiers with the TOC structure and document mappings defined in the plan.
Can multiple team members work on the same plan? #
Yes. Plans support concurrent access, though individual sub-plans may be locked when a user is actively editing them.
Related Articles #
- Plan TOC and Submission Planning — Learn the Plan TOC Editor and regional planner spreadsheet.
- Creating a New Dossier Plan — Create dossiers that execute the plan strategy.
- Dossier Library: Managing Dossiers — Manage dossiers created from plans.
- Filters, Favorites, and Views — Master the filter system used in the Plan Library.
