Emergency Use Listing by WHO
E523136
World Health Organization program
emergency use authorization mechanism
regulatory procedure
risk-based assessment procedure
Emergency Use Listing by WHO is a World Health Organization risk-based procedure that expedites the assessment and authorization of unlicensed vaccines, medicines, and diagnostics for use during public health emergencies.
Statements (48)
| Predicate | Object |
|---|---|
| instanceOf |
World Health Organization program
ⓘ
emergency use authorization mechanism ⓘ regulatory procedure ⓘ risk-based assessment procedure ⓘ |
| administeredBy | World Health Organization NERFINISHED ⓘ |
| appliesTo |
in vitro diagnostics
ⓘ
medical devices for public health emergencies ⓘ medicines ⓘ vaccines ⓘ |
| basedOn |
review of quality, safety and efficacy data
ⓘ
risk–benefit assessment ⓘ |
| beneficiary | countries with limited regulatory capacity ⓘ |
| criterion |
potential benefits must outweigh potential risks
ⓘ
public health emergency of international concern or similar emergency context ⓘ |
| developedBy | World Health Organization NERFINISHED ⓘ |
| differentFrom | full marketing authorization by national regulatory authorities ⓘ |
| enables | emergency procurement of listed products ⓘ |
| geographicScope | global ⓘ |
| hasAbbreviation | EUL NERFINISHED ⓘ |
| hasLanguage | English ⓘ |
| hasOfficialName | Emergency Use Listing procedure NERFINISHED ⓘ |
| hasStakeholder |
United Nations procurement agencies
NERFINISHED
ⓘ
diagnostic manufacturers ⓘ global health partners ⓘ national regulatory authorities ⓘ vaccine manufacturers ⓘ |
| includesStep |
WHO scientific review of available data
ⓘ
assessment of clinical performance ⓘ assessment of manufacturing quality ⓘ post-listing monitoring requirements ⓘ submission of product dossier by manufacturer ⓘ |
| legalNature | non-binding recommendation to Member States ⓘ |
| monitoredBy | World Health Organization NERFINISHED ⓘ |
| purpose |
to expedite assessment of unlicensed health products during public health emergencies
ⓘ
to facilitate availability of quality, safe and effective products during emergencies ⓘ |
| relatedConcept | Emergency Use Authorization ⓘ |
| relatedTo | WHO prequalification program NERFINISHED ⓘ |
| requires |
commitment to continue generating data
ⓘ
good manufacturing practice compliance ⓘ risk management plan ⓘ |
| supports |
Member States regulatory decisions
ⓘ
UN procurement agencies ⓘ |
| supportsGoal | rapid access to essential medical products in emergencies ⓘ |
| timeLimited | true ⓘ |
| usedDuring | public health emergencies ⓘ |
| usedFor |
COVID-19 in vitro diagnostic tests
ⓘ
COVID-19 therapeutics ⓘ COVID-19 vaccines ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.