GMP inspection findings clarification
Correspondence from Pharmaceuticals and Medical Devices Agency regarding PMDA-2022-0043. Type: commitment-request. Risk: low. Category: Clinical.
Correspondence ID
COR-443
Type
commitment-request
Application
Authority
Pharmaceuticals and Medical Devices Agency
Category
Clinical
Risk
Low
Due Date
2025-01-13
Status
Overdue
Owner
Lieselotte van der Berg
Created
2023-08-13
Correspondence Body
Dear PMDA Review Team,
With reference to application PMDA-2022-0043, we wish to address the following:
[Detailed response body regarding request for updated smpc section 4.1]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
study_report_443.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-13 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.