# OnCo record paper-sani-npra-new-active-substances-2017-opera-tirs-2020 (paper). 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/key-papers/paper-sani-npra-new-active-substances-2017-opera-tirs-2020/>
  a schema:ScholarlyArticle ;
  onco:kind "paper" ;
  schema:identifier "paper-sani-npra-new-active-substances-2017-opera-tirs-2020" ;
  schema:name "An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology"@en ;
  schema:description "The baseline study of Malaysia's approval times: 25 new active substances and one biosimilar approved in 2017 took a median of 515 days, of which NPRA took 166 and applicants 131 to answer questions."@en ;
  schema:url <https://onco.cc/key-papers/paper-sani-npra-new-active-substances-2017-opera-tirs-2020/> ;
  schema:dateModified "2026-11-04"^^xsd:date ;
  schema:citation <https://doi.org/10.1007/s43441-020-00140-4>, <https://pubmed.ncbi.nlm.nih.gov/32865804/> ;
  schema:sameAs <https://doi.org/10.1007/s43441-020-00140-4> ;
  schema:datePublished "2020"^^xsd:gYear ;
  schema:author "Sani NM, McAuslane N, Kasbon SH, et al." ;
  onco:institutions <https://onco.cc/institutions/npra-malaysia/> .