Approval Letter for Clinical Trial Implementation
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Micro, Small, and Medium Enterprises (UMKU) Details
Parameter: All
Authority: Minister/Head of the Agency
Requirements:-
Pre-Marketing Clinical Trial Authorization
1. Administrative Requirements
2. Technical Requirements
3. Non-Tax State Revenue (PNBP) Payment
Duration: -
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Response Letter to Notification of Post-Marketing Clinical Trials
1. Administrative Requirements
2. Technical Requirements
3. Non-Tax State Revenue (PNBP) Payment
Duration: -
-
Pre-Marketing Clinical Trial Authorization
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Obligations:
- Conducting Clinical Trials according to the approved protocol methodology and Good Clinical Practice (GCP) standards Duration: -
- Progress Report of Clinical Trial, at least every 6 months Duration: -
- Final Report of Clinical Trial, no later than 30 (thirty) working days after the completion of the clinical trial Duration: -
- Report of Premature Termination of Clinical Trial, no later than 15 (fifteen) working days after the termination of the clinical trial Duration: -
- Report of Adverse Events (AE) if any adverse events occur Duration: -
- Report of Changes/Amendments to Clinical Trial Documents in case of changes Duration: -
Sector: Health
Status: Not available
Belongs to:
32503
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