GMP inspection findings clarification
Correspondence from Health Sciences Authority regarding HSA-2023-0012. Type: query. Risk: medium. Category: Administrative.
Correspondence ID
COR-512
Type
query
Application
Authority
Health Sciences Authority
Category
Administrative
Risk
Medium
Due Date
2025-03-20
Status
In Progress
Owner
Tomoko Ikeda
Created
2024-02-20
Correspondence Body
Dear HSA Review Team,
With reference to application HSA-2023-0012, we wish to address the following:
[Detailed response body regarding deficiency: inadequate paediatric data justification]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.