Information request: manufacturing process change justificat

Correspondence from National Medical Products Administration regarding NMPA-2021-0064. Type: information-request. Risk: medium. Category: Administrative.

Correspondence ID
COR-464
Type
information-request
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Administrative
Risk
Medium
Due Date
2025-01-30
Status
In Progress
Owner
Carlos Mendez
Created
2023-01-29
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0064, 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
Response Assembly
Draft Response Actions:
Response deadline: 2025-01-30 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.