GMP inspection findings clarification

Correspondence from National Medical Products Administration regarding NMPA-2021-0024. Type: commitment-request. Risk: low. Category: Quality.

Correspondence ID
COR-124
Type
commitment-request
Application
NMPA-2021-0024
Authority
National Medical Products Administration
Category
Quality
Risk
Low
Due Date
2025-04-04
Status
In Progress
Owner
Aisha Okonkwo
Created
2022-09-03
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0024, we wish to address the following: [Detailed response body regarding request for benefit-risk assessment addendum] 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_124.xlsxattachment_124_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-04 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.