# OnCo record paper-mohd-sani-npra-approval-times-opera-tirs-2025 (paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)". Whole corpus: https://onco.cc/api/v1/onco.nt
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@prefix onco: <https://onco.cc/ns#> .
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<https://onco.cc/key-papers/paper-mohd-sani-npra-approval-times-opera-tirs-2025/>
  a schema:ScholarlyArticle ;
  onco:kind "paper" ;
  schema:identifier "paper-mohd-sani-npra-approval-times-opera-tirs-2025" ;
  schema:name "Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach"@en ;
  schema:description "NPRA's own measurement, with the Centre for Innovation in Regulatory Science, of how long Malaysia took to approve new medicines: the median fell from 515 calendar days for those approved in 2017 to 399 for those approved in 2019."@en ;
  schema:url <https://onco.cc/key-papers/paper-mohd-sani-npra-approval-times-opera-tirs-2025/> ;
  schema:dateModified "2026-11-04"^^xsd:date ;
  schema:citation <https://doi.org/10.1007/s43441-025-00846-3>, <https://pubmed.ncbi.nlm.nih.gov/40711492/> ;
  schema:sameAs <https://doi.org/10.1007/s43441-025-00846-3> ;
  schema:datePublished "2025"^^xsd:gYear ;
  schema:author "Mohd Sani N, Kasbon SH, Yap KY, et al." ;
  onco:institutions <https://onco.cc/institutions/npra-malaysia/> .