GMP inspection findings clarification
Correspondence from European Medicines Agency regarding EMA-2023-0082. Type: deficiency. Risk: low. Category: Clinical.
Correspondence ID
COR-182
Type
deficiency
Application
Authority
European Medicines Agency
Category
Clinical
Risk
Low
Due Date
2025-02-22
Status
Draft
Owner
Aisha Okonkwo
Created
2024-01-31
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0082, we wish to address the following:
[Detailed response body regarding deficiency letter: missing stability data for 40°c condition]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_182_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-22 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.