Dossier DOS-048
Dossier in eCTD format, version 1.7.4, for application MHRA-2022-0048. The module tree below shows the 5 CTD modules with their component count and status.
Dossier ID
DOS-048
Format
eCTD
Version
1.7.4
Status
Submitted
Application
Created
2023-01-17
Updated
2023-04-30
Total Modules
5
Module Tree
| Module | Title | Components | Status |
|---|---|---|---|
| 1 | Administrative Information and Prescribing Information | 13 | Draft |
| 2 | CTD Summaries | 5 | In Progress |
| 3 | Quality | 7 | Completed |
| 4 | Nonclinical Study Reports | 15 | Completed |
| 5 | Clinical Study Reports | 9 | Completed |
Content Components (showing first 20)
| ID | Section | Title | Version | Format | Words | Status | Owner |
|---|---|---|---|---|---|---|---|
| CC-048 | 3.2.5 | Analytical Methods | 10.7 | Word | 1,031 | Draft | Tomoko Ikeda |
| CC-148 | 2.9.3 | Clinical Overview | 5.5 | 14,762 | Draft | Marcus Webb | |
| CC-248 | 3.9.2 | Drug Substance | 2.0 | HTML | 2,062 | Blocked | Lieselotte van der Berg |
| CC-348 | 5.8.9 | Study Reports – Clinical Pharmacology | 2.3 | HTML | 4,135 | Active | Marcus Webb |
| CC-448 | 3.1.5 | Manufacturing Process | 3.9 | Word | 6,870 | In Progress | Sarah Chen |
| CC-548 | 5.2.4 | Integrated Summary of Efficacy | 7.6 | Word | 2,140 | Completed | Sarah Chen |
| CC-648 | 5.3.1 | Study Reports – Clinical Pharmacology | 12.8 | HTML | 6,632 | Submitted | Aisha Okonkwo |
| CC-748 | 5.9.8 | Study Reports – Safety | 5.8 | HTML | 12,781 | In Progress | Lieselotte van der Berg |
| CC-848 | 2.1.9 | Clinical Summary | 3.9 | Word | 4,328 | Blocked | Priya Sharma |
| CC-948 | 1.8.2 | Patient Labeling | 10.9 | HTML | 3,066 | Submitted | Lieselotte van der Berg |
| CC-1048 | 5.3.2 | Study Reports – Safety | 8.1 | Word | 4,261 | Failed | Sarah Chen |
| CC-1148 | 1.1.9 | Prescribing Information | 4.2 | 9,795 | Pending | Marcus Webb | |
| CC-1248 | 1.8.9 | Patient Labeling | 8.9 | XML | 1,860 | Approved | Aisha Okonkwo |
| CC-1348 | 5.2.5 | Study Reports – Safety | 3.7 | Word | 11,981 | Draft | Nadia Petrova |
| CC-1448 | 1.4.6 | Patient Labeling | 6.6 | XML | 1,128 | Blocked | Dmitri Volkov |
| CC-1548 | 1.5.2 | Patient Labeling | 1.8 | Word | 12,184 | Approved | James O'Brien |
| CC-1648 | 4.2.1 | Carcinogenicity | 2.5 | HTML | 13,589 | Draft | Nadia Petrova |
| CC-1748 | 2.7.1 | Clinical Summary | 1.9 | HTML | 13,600 | Pending | Priya Sharma |
| CC-1848 | 3.4.7 | Manufacturing Process | 7.5 | 9,823 | Submitted | Nadia Petrova | |
| CC-1948 | 3.5.6 | Drug Substance | 12.1 | XML | 10,101 | Failed | Aisha Okonkwo |
Showing 20 of 20 components