Approval for the Use of Drugs in Emergency Conditions (Emergency Use Authorization).

UMKU PB Details

Parameter

  • All

Authority

  • Minister/Head of the Agency

Requirements

  1. Standard and criteria requirements for drug registration; and

    Duration: -

  2. Indonesian Pharmacopoeia standards and/or other analysis methods, standards, and/or requirements.

    Duration: -

Responsibilities

  1. Responsible for the quality and labeling of drugs during the Emergency Use Authorization (EUA) period of the drug.

    Duration: -

  2. Conduct advanced clinical studies/trials on drugs that are currently undergoing clinical trials worldwide to ensure their effectiveness and safety.

    Duration: -

  3. Monitor pharmacovigilance and report side effects of drugs to the head of the agency responsible for drug and food supervision.

    Duration: -

  4. Report the realization of drug import, production, and distribution during the emergency use authorization to the head of the agency responsible for drug and food supervision.

    Duration: -

Sector: Drugs and Food.
Status: Available
Belongs to:
21012

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