# OnCo record idea-reg-joint-scientific-advice-default (idea). 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/ideas/idea-reg-joint-scientific-advice-default/>
  a schema:CreativeWork ;
  onco:kind "idea" ;
  schema:identifier "idea-reg-joint-scientific-advice-default" ;
  schema:name "Joint FDA-EMA-MHRA-PMDA scientific advice by default before pivotal cancer trials"@en ;
  schema:description "Before a company runs its phase 3 cancer trial, FDA, EMA, MHRA, PMDA, Health Canada and TGA would agree the endpoints, comparator, population and statistical plan in one joint written advice letter, so a single trial can support approval everywhere. Today parallel advice is used for a handful of products a year."@en ;
  schema:url <https://onco.cc/ideas/idea-reg-joint-scientific-advice-default/> ;
  schema:dateModified "2026-09-08"^^xsd:date ;
  schema:citation <https://www.ema.europa.eu/en/human-regulatory-overview/research-development/scientific-advice-protocol-assistance/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/>, <https://onco.cc/bottlenecks/b-trial-design/> .