Request for post-marketing commitment progress update

Correspondence from National Medical Products Administration regarding NMPA-2021-0004. Type: information-request. Risk: medium. Category: Quality.

Correspondence ID
COR-004
Type
information-request
Application
NMPA-2021-0004
Authority
National Medical Products Administration
Category
Quality
Risk
Medium
Due Date
2025-04-24
Status
Completed
Owner
Dmitri Volkov
Created
2022-07-11
Correspondence Body
Dear NMPA Review Team, With reference to application NMPA-2021-0004, 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_4.xlsxattachment_4_1.pdf
Response Package
Response package assembled: RP-004