Request for post-marketing commitment progress update

Correspondence from Ministry of Food and Drug Safety regarding MFDS-2020-0010. Type: commitment-request. Risk: high. Category: Quality.

Correspondence ID
COR-210
Type
commitment-request
Application
MFDS-2020-0010
Authority
Ministry of Food and Drug Safety
Category
Quality
Risk
High
Due Date
2025-03-07
Status
In Progress
Owner
Sarah Chen
Created
2023-01-06
Correspondence Body
Dear MFDS Review Team, With reference to application MFDS-2020-0010, 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
data_table_210.xlsx
Response Assembly
Draft Response Actions:
Response deadline: 2025-03-07 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.