# OnCo record japan-conditional-early-approval (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/japan-conditional-early-approval/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "japan-conditional-early-approval" ;
  schema:name "Japan conditional early approval and time-limited approval"@en ;
  schema:alternateName "conditional early approval system"@en, "conditional and time-limited approval"@en, "PMD Act 2019 amendment"@en, "Pharmaceuticals and Medical Devices Act"@en, "regenerative medicine conditional approval"@en, "Japan conditional approval"@en ;
  schema:description "Japan can approve a medicine for a serious disease on early data when a confirmatory trial would be hard to run, on condition that evidence is gathered after launch; for cell and tissue products a 2014 law allows a time-limited approval that must be confirmed within seven years."@en ;
  schema:url <https://onco.cc/terms/japan-conditional-early-approval/> ;
  schema:dateModified "2026-09-17"^^xsd:date ;
  schema:citation <https://www.pmda.go.jp/english/> ;
  onco:tag "law", "jp" ;
  onco:related <https://onco.cc/terms/sakigake/>, <https://onco.cc/terms/accelerated-approval/>, <https://onco.cc/terms/conditional-approval/>, <https://onco.cc/terms/fdora-2022/>, <https://onco.cc/terms/confirmatory-trial/>, <https://onco.cc/terms/regulatory-agencies/>, <https://onco.cc/terms/fast-track-rmat/> ;
  onco:institutions <https://onco.cc/institutions/pmda/> ;
  onco:bottlenecks <https://onco.cc/bottlenecks/b-regulatory-fragmentation/>, <https://onco.cc/bottlenecks/b-trial-design/> .