Request for post-marketing commitment progress update

Correspondence from National Medical Products Administration regarding NMPA-2021-0004. Type: query. Risk: low. Category: Administrative.

Correspondence ID
COR-304
Type
query
Application
NMPA-2021-0004
Authority
National Medical Products Administration
Category
Administrative
Risk
Low
Due Date
2025-04-08
Status
Draft
Owner
Aisha Okonkwo
Created
2024-01-20
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0004, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-08 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.