GMP inspection findings clarification
Correspondence from National Medical Products Administration regarding NMPA-2021-0084. Type: commitment-request. Risk: medium. Category: Clinical.
Correspondence ID
COR-184
Type
commitment-request
Application
Authority
National Medical Products Administration
Category
Clinical
Risk
Medium
Due Date
2025-02-12
Status
Open
Owner
Sarah Chen
Created
2023-01-23
Correspondence Body
Dear NMPA Review Team,
With reference to application NMPA-2021-0084, we wish to address the following:
[Detailed response body regarding question on comparative dissolution data]
We trust this information is satisfactory. Please do not hesitate to contact us for further clarification.
Kind regards,
KCL BioPharm Regulatory Affairs
Attachments
attachment_184_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-02-12 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.