Request for post-marketing commitment progress update

Correspondence from National Medical Products Administration regarding NMPA-2021-0064. Type: deficiency. Risk: medium. Category: Clinical.

Correspondence ID
COR-264
Type
deficiency
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Clinical
Risk
Medium
Due Date
2025-04-05
Status
In Progress
Owner
Sarah Chen
Created
2023-07-16
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0064, we wish to address the following: [Detailed response body regarding query: container closure integrity study methodology] 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_264.pdfattachment_264_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-05 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.