Question on comparative dissolution data
Correspondence from European Medicines Agency regarding EMA-2023-0042. Type: question. Risk: medium. Category: Administrative.
Correspondence ID
COR-342
Type
question
Application
Authority
European Medicines Agency
Category
Administrative
Risk
Medium
Due Date
2025-05-06
Status
Open
Owner
Tomoko Ikeda
Created
2022-12-29
Correspondence Body
Dear EMA Review Team,
With reference to application EMA-2023-0042, we wish to address the following:
[Detailed response body regarding gmp inspection findings clarification]
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_342.pdfattachment_342_1.pdf
Response Assembly
Draft Response Actions:
Response deadline: 2025-05-06 — Assign relevant content components from the dossier and compile a response package using the Content Assembly Workbench.