GMP inspection findings clarification
Correspondence from Medicines and Healthcare products Regulatory Agency regarding MHRA-2022-0008. Type: commitment-request. Risk: medium. Category: Administrative.
Correspondence ID
COR-308
Type
commitment-request
Application
Authority
Medicines and Healthcare products Regulatory Agency
Category
Administrative
Risk
Medium
Due Date
2025-04-23
Status
Open
Owner
Lieselotte van der Berg
Created
2023-08-25
Correspondence Body
Dear MHRA Review Team,
With reference to application MHRA-2022-0008, we wish to address the following:
[Detailed response body regarding request for additional clinical data on primary endpoint]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
data_table_308.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-23 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.