# OnCo record eu-orphan-regulation (term). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
@prefix schema: <https://schema.org/> .
@prefix onco: <https://onco.cc/ns#> .
@prefix xsd: <http://www.w3.org/2001/XMLSchema#> .

<https://onco.cc/terms/eu-orphan-regulation/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "eu-orphan-regulation" ;
  schema:name "Regulation (EC) No 141/2000: EU orphan medicines"@en ;
  schema:alternateName "Regulation 141/2000"@en, "EU Orphan Regulation"@en, "Orphan Medicinal Products Regulation"@en, "orphan medicinal product"@en, "orphan medicinal products"@en, "ten-year market exclusivity"@en, "COMP"@en, "Committee for Orphan Medicinal Products"@en ;
  schema:description "The EU's 2000 answer to the US Orphan Drug Act: ten years during which no similar medicine may be authorised for the same rare disease, plus fee reductions and scientific advice, for conditions affecting no more than 5 in 10,000 people."@en ;
  schema:url <https://onco.cc/terms/eu-orphan-regulation/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://eur-lex.europa.eu/eli/reg/2000/141/oj>, <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/orphan-designation-research-development> ;
  onco:tag "law", "eu" ;
  onco:related <https://onco.cc/terms/orphan-designation/>, <https://onco.cc/terms/orphan-drug-act/>, <https://onco.cc/terms/orphan-drug/>, <https://onco.cc/terms/eu-regulation-726-2004/>, <https://onco.cc/terms/eu-paediatric-regulation/>, <https://onco.cc/terms/eu-pharma-package/>, <https://onco.cc/terms/rare-cancers/>, <https://onco.cc/terms/amnog/>, <https://onco.cc/terms/eu-data-exclusivity/> ;
  onco:institutions <https://onco.cc/institutions/ema/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-rare-cancers/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/> .