Approval for the Implementation of Cosmetic Clinical Trials.
UMKU Details
Parameter: All
Authority: Minister/Head of Agency
Requirements and Obligations:
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1. Compliance with the Standards and Requirements for the Approval of Clinical Trials of Traditional Medicines, Quasi-Medicines, Health Supplements, and Cosmetics.
Duration: -
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2. Evidence of Payment of PNBP
Duration: -
Obligations:
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1. Report serious drug adverse effects.
Duration: -
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2. Report progress of clinical trials.
Duration: -
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3. Report the completion of clinical trials.
Duration: -
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4. Conduct clinical trials in accordance with the approved protocol and Good Clinical Practice standards. During the conduct of clinical trials.
Duration: -
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5. Report the termination of clinical trials.
Jangka Waktu: -
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6. Report changes/amendments to clinical trial documents.
Jangka Waktu: -
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