# OnCo record bpca-prea (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/bpca-prea/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "bpca-prea" ;
  schema:name "Paediatric drug laws: BPCA and PREA"@en ;
  schema:alternateName "BPCA"@en, "PREA"@en, "Best Pharmaceuticals for Children Act"@en, "Pediatric Research Equity Act"@en, "paediatric exclusivity"@en, "pediatric exclusivity"@en, "six-month paediatric exclusivity"@en, "paediatric study plan"@en, "written request"@en ;
  schema:description "Two US laws, one a carrot and one a stick, that get new drugs studied in children: BPCA gives six extra months of exclusivity for doing requested paediatric studies, and PREA requires paediatric assessments, though until 2020 cancer drugs mostly escaped it."@en ;
  schema:url <https://onco.cc/terms/bpca-prea/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Best_Pharmaceuticals_for_Children_Act> ;
  schema:citation <https://en.wikipedia.org/wiki/Best_Pharmaceuticals_for_Children_Act>, <https://www.fda.gov/drugs/development-resources/pediatric-research-equity-act-prea>, <https://www.fda.gov/drugs/development-resources/best-pharmaceuticals-children-act-bpca> ;
  onco:tag "law", "us" ;
  onco:related <https://onco.cc/terms/race-for-children-act/>, <https://onco.cc/terms/eu-paediatric-regulation/>, <https://onco.cc/terms/fdasia-2012/>, <https://onco.cc/terms/us-regulatory-exclusivity/>, <https://onco.cc/terms/orphan-drug-act/>, <https://onco.cc/terms/hatch-waxman/> ;
  onco:institutions <https://onco.cc/institutions/fda-oce/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-rare-cancers/>, <https://onco.cc/bottlenecks/b-incentive-misalignment/> .