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: -