Approval for the Implementation of Health Supplement Clinical Trials.

UMKU Details

  • Parameter: All
  • Authority: Minister/Head of Agency

Requirements

  1. Compliance with the Clinical Trial Implementation Standards for Traditional Medicines, Quasi-Medicines, Health Supplements, and Cosmetics.

    2. Duration: -

  2. Evidence of Payment of PNBP

    3. Duration: -

Responsibilities

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

    2. Duration: -

  2. Report serious drug adverse effects.

    3. Duration: -

  3. Report progress of clinical trials.

    4. Duration: -

  4. Report the completion of clinical trials.

    5. Duration: -

  5. Report the termination of clinical trials.

    6. Duration: -

  6. Report changes/amendments to clinical trial documents.

    7. Duration: -

Sector: Drugs and Food.
Status: Available
Belongs to:
10799
11040
11090
20232
21012
21022
46334
46339
46441
46442
46443
47111
47112
47191
47723
47724
47911
47914
47999
72103
74117

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