Approval for the Implementation of Cosmetic Clinical Trials.

UMKU Details

Parameter: All

Authority: Minister/Head of Agency

Requirements and Obligations:

  1. 1. Compliance with the Standards and Requirements for the Approval of Clinical Trials of Traditional Medicines, Quasi-Medicines, Health Supplements, and Cosmetics.

    Duration: -

  2. 2. Evidence of Payment of PNBP

    Duration: -

Obligations:

  1. 1. Report serious drug adverse effects.

    Duration: -

  2. 2. Report progress of clinical trials.

    Duration: -

  3. 3. Report the completion of clinical trials.

    Duration: -

  4. 4. Conduct clinical trials in accordance with the approved protocol and Good Clinical Practice standards. During the conduct of clinical trials.

    Duration: -

  5. 5. Report the termination of clinical trials.

    Jangka Waktu: -

  6. 6. Report changes/amendments to clinical trial documents.

    Jangka Waktu: -

Sector: Drugs and Food.
Status: Available

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