Request for benefit-risk assessment addendum

Correspondence from National Medical Products Administration regarding NMPA-2021-0044. Type: commitment-request. Risk: low. Category: Labeling.

Correspondence ID
COR-444
Type
commitment-request
Application
NMPA-2021-0044
Authority
National Medical Products Administration
Category
Labeling
Risk
Low
Due Date
2024-12-10
Status
Draft
Owner
Priya Sharma
Created
2023-08-12
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0044, we wish to address the following: [Detailed response body regarding gmp inspection findings clarification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
attachment_444_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-10 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.