Query regarding bioequivalence study design

Correspondence from National Medical Products Administration regarding NMPA-2021-0044. Type: question. Risk: low. Category: Nonclinical.

Correspondence ID
COR-344
Type
question
Application
NMPA-2021-0044
Authority
National Medical Products Administration
Category
Nonclinical
Risk
Low
Due Date
2024-12-16
Status
Draft
Owner
James O'Brien
Created
2022-06-30
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0044, we wish to address the following: [Detailed response body regarding request for updated smpc section 4.1] 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: 2024-12-16 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.