Conditional Marketing Authorization by European Medicines Agency
E523137
Conditional Marketing Authorization by the European Medicines Agency is a fast-track regulatory pathway that allows earlier approval of medicines, such as COVID-19 vaccines, based on less comprehensive data than normally required, provided that the benefits outweigh the risks and additional data will be supplied post-approval.
Statements (49)
| Predicate | Object |
|---|---|
| instanceOf |
fast-track marketing authorization
ⓘ
regulatory approval pathway ⓘ |
| aimsTo |
facilitate earlier availability of promising therapies
ⓘ
speed up access to medicines ⓘ support response to public health emergencies ⓘ |
| appliesTo |
COVID-19 vaccines
ⓘ
innovative medicines ⓘ medicinal products for human use ⓘ medicines addressing unmet medical needs ⓘ medicines for public health emergencies ⓘ |
| basedOn |
benefit-risk balance considered positive
ⓘ
less comprehensive clinical data than normally required ⓘ |
| canBeConvertedTo | standard marketing authorization ⓘ |
| condition |
benefits outweigh the risks
ⓘ
immediate availability outweighs risk of less complete data ⓘ unmet medical need is addressed ⓘ |
| conversionCondition |
fulfilment of specific obligations
ⓘ
submission of comprehensive clinical data ⓘ |
| difference |
granted on the basis of less complete data
ⓘ
subject to specific post-authorization obligations ⓘ |
| differsFrom | standard marketing authorization ⓘ |
| exampleProductType |
mRNA COVID-19 vaccines
ⓘ
viral vector COVID-19 vaccines ⓘ |
| grantedBy | European Commission NERFINISHED ⓘ |
| includesRequirement |
periodic benefit-risk evaluation reports
ⓘ
updated product information as new data emerge ⓘ |
| regulatedBy |
Commission Regulation (EC) No 507/2006
NERFINISHED
ⓘ
Regulation (EC) No 726/2004 NERFINISHED ⓘ |
| regulates | early approval of medicines ⓘ |
| relatedTo |
pharmacovigilance system
ⓘ
risk management system ⓘ |
| renewable | true ⓘ |
| requires |
annual renewal of authorization
ⓘ
completion of ongoing or new studies ⓘ comprehensive risk management plan ⓘ post-authorization efficacy data ⓘ post-authorization safety data ⓘ specific obligations for the marketing authorization holder ⓘ submission of additional data after approval ⓘ |
| scientificAssessmentBy | European Medicines Agency NERFINISHED ⓘ |
| scope |
European Economic Area
NERFINISHED
ⓘ
European Union NERFINISHED ⓘ |
| timeLimited | true ⓘ |
| usedDuring | COVID-19 pandemic NERFINISHED ⓘ |
| usedFor |
emergency situations in response to public health threats
ⓘ
life-threatening diseases ⓘ orphan medicines ⓘ seriously debilitating diseases ⓘ |
| validityPeriod | 1 year ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.
COVID-19 vaccines
→
regulatoryApproval
→
Conditional Marketing Authorization by European Medicines Agency
ⓘ