Information request: manufacturing process change justificat

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

Correspondence ID
COR-564
Type
commitment-request
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Labeling
Risk
Medium
Due Date
2025-04-26
Status
In Progress
Owner
Priya Sharma
Created
2022-07-21
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0064, we wish to address the following: [Detailed response body regarding question on comparative dissolution data] 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_564.xlsxattachment_564_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-04-26 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.