sMAA Submission Plan 44

Open Content Assembly

This submission plan coordinates owners, milestone dependencies, and readiness controls for Glucovex. Teams use it to monitor timeline health, resolve blockers, and decide whether content is publish-ready for sequence assembly. Readiness is calculated from deterministic component approval status across linked dossiers, rather than manual estimates. Use the edit and content assembly actions to move directly into corrective work.

Plan ID
PLAN-044
Application
NMPA-2021-0044
Target Date
2025-09-23
Status
In Progress
Owner
Sarah Chen
Created
2022-07-29
Readiness Score
10/100
Calculated from 2 approved of 20 linked content components.
Blockers
8 components are missing approval snapshots.
3 components still have unresolved review comments.
Quality review gate not passed
Milestone Dependency Strip
Data cutoff
Publishing start
CSR review
Protocol finalization
QC check
Regulatory review
Quality review
Module 5 compilation
Module 3 update
Statistical analysis plan lock
MilestoneDue DateOwnerDependenciesDependency IndicatorsCompleted
Data cutoff2025-02-01Sarah ChenNoneIndependentYes
Publishing start2025-02-26Tomoko IkedaNoneIndependentNo
CSR review2025-03-27Priya SharmaPLAN-044-MS-002DependentYes
Protocol finalization2025-04-24Tomoko IkedaNoneIndependentNo
QC check2025-05-18Priya SharmaPLAN-044-MS-004DependentNo
Regulatory review2025-06-25Sarah ChenPLAN-044-MS-005DependentNo
Quality review2025-07-13Aisha OkonkwoNoneIndependentYes
Module 5 compilation2025-08-19Tomoko IkedaPLAN-044-MS-007DependentYes
Module 3 update2025-09-19Aisha OkonkwoNoneIndependentNo
Statistical analysis plan lock2025-11-06Carlos MendezNoneIndependentNo