# OnCo record b-regulatory-fragmentation (bottleneck). 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/bottlenecks/b-regulatory-fragmentation/>
  a schema:Thing ;
  onco:kind "bottleneck" ;
  schema:identifier "b-regulatory-fragmentation" ;
  schema:name "Regulatory divergence between regions"@en ;
  schema:description "Regulatory divergence means a drug approved in one country can take years to reach another, or never arrive."@en ;
  schema:url <https://onco.cc/bottlenecks/b-regulatory-fragmentation/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.fda.gov/about-fda/oncology-center-excellence/project-orbis>, <https://doi.org/10.1056/NEJMsa1200223>, <https://www.ich.org/>, <https://health.ec.europa.eu/health-technology-assessment/regulation-health-technology-assessment_en> ;
  onco:related <https://onco.cc/collections/fda-approvals/>, <https://onco.cc/collections/esmo-guidelines/>, <https://onco.cc/collections/eudract-ctis/>, <https://onco.cc/ideas/idea-reg-orbis-work-sharing/>, <https://onco.cc/ideas/idea-reg-reliance-90-day-lmic/>, <https://onco.cc/ideas/idea-reg-single-global-dossier/>, <https://onco.cc/ideas/idea-reg-joint-scientific-advice-default/>, <https://onco.cc/ideas/idea-reg-realtime-streaming-submission/>, <https://onco.cc/ideas/idea-reg-conditional-approval-sunset/>, <https://onco.cc/ideas/idea-reg-confirmatory-trial-escrow/>, <https://onco.cc/ideas/idea-reg-public-assessment-reports-all/>, <https://onco.cc/ideas/idea-reg-mutual-recognition-inspections-atmp/>, <https://onco.cc/ideas/idea-reg-global-trial-application-portal/>, <https://onco.cc/ideas/idea-reg-diagnostic-reliance-pathway/>, <https://onco.cc/ideas/idea-reg-single-paediatric-plan/>, <https://onco.cc/ideas/idea-reg-tumour-agnostic-reliance/>, <https://onco.cc/ideas/idea-reg-label-divergence-index/>, <https://onco.cc/ideas/idea-reg-approval-access-lag-tracker/>, <https://onco.cc/ideas/idea-reg-joint-regulator-hta-plan/>, <https://onco.cc/ideas/idea-reg-mrct-no-bridging/>, <https://onco.cc/ideas/idea-reg-african-medicines-agency-oncology/>, <https://onco.cc/ideas/idea-reg-open-source-dossier-tools/>, <https://onco.cc/ideas/idea-reg-shared-ai-review-assistant/>, <https://onco.cc/ideas/idea-reg-shared-postmarketing-registry-condition/>, <https://onco.cc/ideas/idea-reg-manufacturing-change-passport/>, <https://onco.cc/ideas/idea-reg-orphan-designation-reciprocity/>, <https://onco.cc/ideas/idea-reg-publish-all-rejections/>, <https://onco.cc/ideas/idea-moon-reciprocal-tumour-agnostic-approvals/> ;
  onco:drugs <https://onco.cc/drugs/trastuzumab-biosimilars/>, <https://onco.cc/drugs/toripalimab/>, <https://onco.cc/drugs/tislelizumab/>, <https://onco.cc/drugs/serplulimab/>, <https://onco.cc/drugs/camrelizumab/> ;
  onco:companies <https://onco.cc/companies/hengrui/>, <https://onco.cc/companies/beone/>, <https://onco.cc/companies/akeso/>, <https://onco.cc/companies/henlius/> ;
  onco:institutions <https://onco.cc/institutions/esmo/>, <https://onco.cc/institutions/asco/>, <https://onco.cc/institutions/ncc-japan/>, <https://onco.cc/institutions/cams-cancer-hospital/> ;
  onco:terms <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/breakthrough-designation/>, <https://onco.cc/terms/biosimilar/>, <https://onco.cc/terms/standard-of-care/> ;
  onco:keyPapers <https://onco.cc/key-papers/paper-downing-n-engl-j-med/> .