# OnCo record eu-paediatric-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-paediatric-regulation/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "eu-paediatric-regulation" ;
  schema:name "Regulation (EC) No 1901/2006: EU paediatric medicines"@en ;
  schema:alternateName "Regulation 1901/2006"@en, "EU Paediatric Regulation"@en, "Paediatric Regulation"@en, "paediatric investigation plan"@en, "paediatric investigation plans"@en, "PIP"@en, "PIPs"@en, "PDCO"@en, "Paediatric Committee"@en, "class waiver"@en, "class waivers"@en, "PUMA"@en ;
  schema:description "Since 2007 every new medicine in the EU must come with an agreed plan for studying it in children, or a waiver, and completing the plan earns six extra months of patent protection; a loophole let adult-cancer drugs skip children, which is now being closed."@en ;
  schema:url <https://onco.cc/terms/eu-paediatric-regulation/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://eur-lex.europa.eu/eli/reg/2006/1901/oj>, <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/paediatric-medicines-research-development> ;
  onco:tag "law", "eu" ;
  onco:related <https://onco.cc/terms/race-for-children-act/>, <https://onco.cc/terms/bpca-prea/>, <https://onco.cc/terms/eu-orphan-regulation/>, <https://onco.cc/terms/eu-regulation-726-2004/>, <https://onco.cc/terms/spc/>, <https://onco.cc/terms/eu-pharma-package/>, <https://onco.cc/terms/rare-cancers/> ;
  onco:institutions <https://onco.cc/institutions/ema/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-rare-cancers/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/> .