Approval for the Use of Drugs in Emergency Conditions (Emergency Use Authorization).
UMKU PB Details
Parameter
- All
Authority
- Minister/Head of the Agency
Requirements
-
Standard and criteria requirements for drug registration; and
Duration: -
-
Indonesian Pharmacopoeia standards and/or other analysis methods, standards, and/or requirements.
Duration: -
Responsibilities
-
Responsible for the quality and labeling of drugs during the Emergency Use Authorization (EUA) period of the drug.
Duration: -
-
Conduct advanced clinical studies/trials on drugs that are currently undergoing clinical trials worldwide to ensure their effectiveness and safety.
Duration: -
-
Monitor pharmacovigilance and report side effects of drugs to the head of the agency responsible for drug and food supervision.
Duration: -
-
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: -
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