Committee for Orphan Medicinal Products
E24718
The Committee for Orphan Medicinal Products is a specialized expert body that evaluates and advises on the designation and development of medicines for rare diseases within the European Union.
Observed surface forms (1)
| Surface form | Occurrences |
|---|---|
| Committee for Orphan Medicinal Products within the European Medicines Agency | 1 |
Statements (47)
| Predicate | Object |
|---|---|
| instanceOf |
European Union body
ⓘ
expert body ⓘ regulatory advisory committee ⓘ scientific committee ⓘ |
| abbreviation | COMP ⓘ |
| appliesTo | human medicinal products ⓘ |
| collaboratesWith |
European Commission
ⓘ
national competent authorities of EU Member States ⓘ patient organizations ⓘ pharmaceutical industry ⓘ |
| composition |
experts in rare diseases and orphan drugs
ⓘ
members nominated by EU Member States ⓘ members nominated by the European Commission ⓘ patient representatives ⓘ |
| country | European Union ⓘ |
| field |
drug development
ⓘ
orphan medicinal products ⓘ pharmaceutical regulation ⓘ rare diseases ⓘ |
| focus | conditions affecting not more than 5 in 10,000 people in the EU ⓘ |
| goal |
facilitate development and availability of orphan medicines in the EU
ⓘ
improve treatment options for patients with rare diseases ⓘ |
| grants | opinions that can lead to market exclusivity incentives ⓘ |
| inception | 2000 ⓘ |
| jurisdiction | European Union ⓘ |
| language | English ⓘ |
| legalBasis |
Regulation (EC) No 141/2000
ⓘ
Regulation (EC) No 726/2004 ⓘ |
| locatedIn |
Amsterdam
ⓘ
Netherlands ⓘ |
| meetsAt | European Medicines Agency headquarters ⓘ |
| parentOrganization | European Medicines Agency ⓘ |
| partOf | European Medicines Agency ⓘ |
| provides | scientific advice on orphan drug development strategies ⓘ |
| regulates | orphan medicinal product designation in the EU ⓘ |
| role |
advise on development of medicines for rare diseases
ⓘ
advise the European Commission on orphan medicinal products ⓘ contribute to guidelines on orphan drug development ⓘ evaluate applications for orphan designation of medicines ⓘ provide opinions on orphan medicinal product designation ⓘ support implementation of EU orphan drug legislation ⓘ |
| subjectOf | EU orphan drug policy ⓘ |
| typeOfJurisdiction | supranational ⓘ |
| website | https://www.ema.europa.eu/en/committees/committee-orphan-medicinal-products-comp ⓘ |
| worksOn |
orphan designation procedures
ⓘ
protocol assistance for orphan medicines ⓘ review of maintenance or withdrawal of orphan designation ⓘ |
Referenced by (3)
Full triples — surface form annotated when it differs from this entity's canonical label.
this entity surface form:
Committee for Orphan Medicinal Products within the European Medicines Agency
subject surface form:
European Medicines Agency