COMP
E128447
COMP is a scientific committee within the European Medicines Agency responsible for evaluating and advising on orphan medicinal products for rare diseases in the European Union.
All labels observed (1)
| Label | Occurrences |
|---|---|
| COMP canonical | 1 |
Statements (45)
| Predicate | Object |
|---|---|
| instanceOf |
committee of the European Medicines Agency
ⓘ
scientific committee ⓘ |
| abbreviation | COMP ⓘ |
| country | European Union ⓘ |
| decisionType | scientific opinion ⓘ |
| establishedBy | European Union legislation on orphan medicinal products ⓘ |
| field |
orphan medicinal products
ⓘ
rare diseases ⓘ regulation of medicinal products ⓘ |
| fullName | Committee for Orphan Medicinal Products ⓘ |
| hasMemberType |
European Commission representative
ⓘ
experts nominated by EU Member States ⓘ patient representatives ⓘ |
| hasObjective |
to advise the European Commission on orphan designation
ⓘ
to ensure appropriate evaluation of orphan medicinal products ⓘ to promote the development of medicines for rare diseases ⓘ |
| jurisdiction | European Union ⓘ |
| language | English ⓘ |
| locatedIn |
Amsterdam
ⓘ
Netherlands ⓘ |
| meetingFrequency | monthly ⓘ |
| parentOrganization | European Medicines Agency ⓘ |
| partOf |
European Medicines Agency
ⓘ
surface form:
scientific committees of the European Medicines Agency
|
| regulates | orphan medicinal products in the European Union ⓘ |
| reportsTo | Management Board of the European Medicines Agency ⓘ |
| role |
advises on orphan medicinal products
ⓘ
assesses eligibility for orphan designation criteria ⓘ contributes to EU orphan drug policy implementation ⓘ evaluates applications for orphan designation ⓘ issues opinions on orphan designation ⓘ provides scientific advice on orphan medicines ⓘ supports development of medicines for rare diseases ⓘ |
| scope |
orphan medicinal products for human use
ⓘ
rare diseases affecting not more than 5 in 10,000 people in the EU ⓘ |
| subjectOf | EU orphan drug legislation ⓘ |
| topic |
incentives for orphan medicinal products
ⓘ
orphan designation criteria ⓘ prevalence of rare diseases in the EU ⓘ significant benefit of orphan medicines ⓘ |
| usesLegalBasis | Regulation (EC) No 141/2000 on orphan medicinal products ⓘ |
| website | https://www.ema.europa.eu/en/committees/comp-committee-orphan-medicinal-products ⓘ |
| worksWith |
European Commission
ⓘ
healthcare professionals ⓘ national competent authorities of EU Member States ⓘ patient organizations ⓘ |
Referenced by (1)
Full triples — surface form annotated when it differs from this entity's canonical label.