Emergency Use Listing by WHO

E523136

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.

All labels observed (4)

How this entity was disambiguated

Statements (48)

Predicate Object
instanceOf World Health Organization program ⓘ
emergency use authorization mechanism ⓘ
regulatory procedure ⓘ
risk-based assessment procedure ⓘ
administeredBy World Health Organization ⓘ
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 ⓘ
differentFrom full marketing authorization by national regulatory authorities ⓘ
enables emergency procurement of listed products ⓘ
geographicScope global ⓘ
hasAbbreviation EUL ⓘ
hasLanguage English ⓘ
hasOfficialName Emergency Use Listing procedure ⓘ
hasStakeholder United Nations procurement agencies ⓘ
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 ⓘ
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 ⓘ
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 ⓘ

How these facts were elicited

Referenced by (4)

Full triples — surface form annotated when it differs from this entity's canonical label.

COVID-19 vaccines → regulatoryApproval → Emergency Use Listing by WHO ⓘ
Vaxzevria COVID-19 vaccine → hasRegulatoryApproval → World Health Organization Emergency Use Listing ⓘ
linked to: Emergency Use Listing by WHO
Emergency Use Listing by WHO → hasOfficialName → Emergency Use Listing procedure ⓘ
linked to: Emergency Use Listing by WHO
BNT162b2 → hasRegulatoryApproval → WHO Emergency Use Listing ⓘ
linked to: Emergency Use Listing by WHO