Query regarding bioequivalence study design

Correspondence from National Medical Products Administration regarding NMPA-2021-0004. Type: information-request. Risk: high. Category: Labeling.

Correspondence ID
COR-504
Type
information-request
Application
NMPA-2021-0004
Authority
National Medical Products Administration
Category
Labeling
Risk
High
Due Date
2024-12-06
Status
Overdue
Owner
Tomoko Ikeda
Created
2023-01-15
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0004, we wish to address the following: [Detailed response body regarding information request: manufacturing process change justification] We trust this information is satisfactory. Please do not hesitate to contact us for further clarification. Kind regards, KCL BioPharm Regulatory Affairs
Attachments
study_report_504.pdfattachment_504_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2024-12-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.