Query regarding bioequivalence study design

Correspondence from South African Health Products Regulatory Authority regarding SAHPRA-2022-0078. Type: commitment-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-078
Type
commitment-request
Application
SAHPRA-2022-0078
Authority
South African Health Products Regulatory Authority
Category
Administrative
Risk
Medium
Due Date
2025-02-20
Status
Open
Owner
Aisha Okonkwo
Created
2024-02-03
Correspondence Body
Dear SAHPRA Review Team, With reference to application SAHPRA-2022-0078, 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
data_table_78.xlsxattachment_78_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-20 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.