# OnCo record regulatory-agencies (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/regulatory-agencies/>
  a schema:DefinedTerm ;
  onco:kind "term" ;
  schema:identifier "regulatory-agencies" ;
  schema:name "Regulators beyond the FDA (EMA/CHMP, MHRA, PMDA, NMPA, TGA)"@en ;
  schema:alternateName "CHMP"@en, "Committee for Medicinal Products for Human Use"@en, "MHRA"@en, "PMDA"@en, "NMPA"@en, "TGA"@en, "Health Canada"@en, "Swissmedic"@en, "ANVISA"@en, "regulator"@en, "regulators"@en, "regulatory agency"@en, "regulatory agencies"@en, "regulatory approval"@en, "marketing authorisation"@en, "marketing authorization"@en, "European Commission approval"@en, "EU approval"@en, "approved in the EU"@en, "approved in Japan"@en, "approved in China"@en, "approved in the UK"@en, "multiregional"@en, "multi-regional trial"@en, "China-only data"@en, "reliance pathway"@en, "Access Consortium"@en, "marketing authorisations"@en, "reliance pathways"@en ;
  schema:description "Every country or bloc has its own drug regulator: the EMA (with its CHMP committee) for the EU, the MHRA for the UK, the PMDA for Japan, the NMPA for China, the TGA for Australia. The same drug can be approved in one place years before another, or on different evidence."@en ;
  schema:url <https://onco.cc/terms/regulatory-agencies/> ;
  schema:dateModified "2026-09-09"^^xsd:date ;
  schema:sameAs <https://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods> ;
  schema:citation <https://en.wikipedia.org/wiki/Regulation_of_therapeutic_goods> ;
  onco:related <https://onco.cc/terms/bla-nda/>, <https://onco.cc/terms/conditional-approval/>, <https://onco.cc/terms/hta/> ;
  onco:sections <https://onco.cc/fronts/drug-discovery/> ;
  onco:technologies <https://onco.cc/terms/project-orbis/> .