Request for benefit-risk assessment addendum

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

Correspondence ID
COR-064
Type
deficiency
Application
NMPA-2021-0064
Authority
National Medical Products Administration
Category
Administrative
Risk
Medium
Due Date
2025-04-25
Status
Completed
Owner
Carlos Mendez
Created
2023-06-16
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_64.pdf
Response Package
Response package assembled: RP-064