Approval for the Implementation of Quasi-Drug Clinical Trials.
UMKU Details
Parameter: All
Authority: Minister/Head of Agency
Requirements
- Compliance with the Standards and Requirements for the Approval of Clinical Trials of Traditional Medicines, Quasi-Medicines, Health Supplements, and Cosmetics.
- Duration: -
Responsibilities
- Report the progress of clinical trials.
- Duration: -
- Report the completion of clinical trials.
- Duration: -
- Conduct clinical trials in accordance with the approved protocol and Good Clinical Practice standards. During the conduct of clinical trials.
- Duration: -
- Report serious drug adverse effects.
- Duration: -
- Report the termination of clinical trials.
- Duration: -
- Report changes/amendments to clinical trial documents.
- Duration: -
Sector: Drugs and Food.
Status: Available
Belongs to:
11040
47191
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