Project Space Lifecycle

The Project Space policy is used by object types such as Project Space, Design Project, Project Snapshot, Experiment, Submission, CAPA, Change Project, Submission Master Record, Business Initiative Project, Product Development Project, and Product Management Project.

This page discusses:

Draft

For Project Space projects, as used in Project Management, the project space object owner or lead can add team members, create phases and tasks, and assign them to members.

For Submission projects, the Regulatory Lead creates the submission project (possibly from a submission template) and connects it to a product, defines the schedule for submitting the dossier, and adds a regulatory calendar template to the schedule.

The Regulatory Lead defines the regulatory information for the submission depending on the submission type defined by the regulatory context for the submission project:

  • Centralized Procedure submission type: add leading country and following countries
  • Mutual Recognition Procedure or Decentralized Procedure: add countries to the submission

The Regulatory Lead defines the regulatory information for the product, such as storage conditions and indications. The Regulatory Lead promotes the submission project to the Ready state.

For Submission Master Records, when you promote a submission project for an Initial Submission to "To Do", Market Registration creates a submission master record in the Draft state.

When promoting a submission project from Draft to To Do, if the Group Products Under One MA field on the regulatory information Properties page of the submission project is set to No, Market Registration creates a separate market authorization and market authorization change for each product for each country. When promoting a submission project from Draft to To Do, if the Group Products Under One MA field on the regulatory information Properties page of the submission project is set to Yes, Market Registrationn creates a single market authorization and market authorization change for all products for each country.

To Do

For Project Space projects, when the project space object is promoted to this state, the assigned tasks are available to the assignees.

For Submission projects, an initial Submission is promoted to To Do, Market Registration creates a submission master record, market authorization and market authorization change object, and it sets the Scope of Authorization attribute for those items to Full.

For a submission project that uses the Restricted Authorization regulatory activity category, Market Registration creates a submission master record, market authorization and market authorization change object, and it sets the Scope of Authorization attribute for those items to Restricted.

The Regulatory Lead creates requests for work and assigns them to the appropriate people. Requests involve the work required to prepare, review, and submit the regulatory dossier.

When all tasks required to complete the Dossier Ready milestone are completed, Market Registration promotes the submission project to the In Work state.

In Work

For Project Space projects, when the task assignees start working on the tasks, the project space object advances to this state.

For Submission projects, the Regulatory Users complete all tasks required for the Dossier Published, Dossier Submitted, and Dossier Received milestones.

After the regulatory authority receives the dossier, the Regulatory Lead manages correspondence, and question-and-answer phase of the submission process.

The Regulatory Lead, after receiving market authorization from the regulatory authority, updates the Regulatory Information for the submission project with the market authorization details, and enters the End Date for the Market Authorization milestone in the schedule.

Market Registration adds an approval route to the lifecycle for the submission project, and promotes the submission project to the In Review state. The route includes approval tasks for reviewing the submission results.

In Approval

For Project Space projects, when all phases are completed, the project space object is promoted to this state.

For CAPA projects, when a CAPA is promoted to the In Approval state, an approval route is automatically created between the In Approval and Completed states. A task is assigned to the CAPA owner for approving the CAPA . If the CAPA is demoted back to the In Approval state, a new route is created between the In Approval and Completed states.

Note: You cannot manually promote a CAPA from the In Approval state to the Completed state.

For Submission projects, all involved Regulatory Users approve their tasks. The Regulatory Lead updates the market authorization change, and approves it for update. Market Registration enters "Consensus Reached" for the dossier submission, and promotes the submission project to Completed.

Completed

For Project Space projects, once the owner approves the route in between the In Approval and Completed states, the object is automatically promoted to the Completed state.

For Submission projects, the project remains in the Completed state until another regulatory activity requires action, such as a renewal supplement, repeal, or other activity. At that point, a new submission project for that purpose is created, and this submission project is promoted to Archived.

Archived

For Project Space projects, the project owner can move the unused, completed project space object to this state.

For Submission Projects, archived projects are obsolete and used as reference only. You cannot promote or demote a submission project after it is archived.

For Submission Master Records, when all market authorizations associated with a submission master record have been promoted to Obsolete, Market Registration automatically promotes the submission master record to Archived.