Request for additional clinical data on primary endpoint

Correspondence from National Medical Products Administration regarding NMPA-2021-0084. Type: question. Risk: high. Category: Clinical.

Correspondence ID
COR-284
Type
question
Application
NMPA-2021-0084
Authority
National Medical Products Administration
Category
Clinical
Risk
High
Due Date
2025-01-09
Status
Draft
Owner
Lieselotte van der Berg
Created
2023-09-28
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0084, 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
attachment_284_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-09 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.