Approval for the Implementation of Quasi-Drug Clinical Trials.

UMKU Details

Parameter: All

Authority: Minister/Head of Agency

Requirements

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

Responsibilities

  1. Report the progress of clinical trials.
  2. Duration: -
  3. Report the completion of clinical trials.
  4. Duration: -
  5. Conduct clinical trials in accordance with the approved protocol and Good Clinical Practice standards. During the conduct of clinical trials.
  6. Duration: -
  7. Report serious drug adverse effects.
  8. Duration: -
  9. Report the termination of clinical trials.
  10. Duration: -
  11. Report changes/amendments to clinical trial documents.
  12. Duration: -
Sector: Drugs and Food.
Status: Available

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