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