{"entity":{"id":"paper-mohd-sani-npra-approval-times-opera-tirs-2025","kind":"paper","name":"Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach","aka":[],"tldr":"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.","summary":"NPRA has worked with the Centre for Innovation in Regulatory Science since 2018 to analyse approval of new active substances and biosimilars. NPRA representatives completed the Optimizing Efficiencies in Regulatory Agencies (OpERA) country report on the review process and registration pathways, and supplied milestone data on 24 new active substances approved in 2019, compared with the 2017 baseline.","asOf":"2026-11-04","links":[{"label":"Ther Innov Regul Sci 2025","url":"https://doi.org/10.1007/s43441-025-00846-3"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/40711492/"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["npra-malaysia"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"journal":"Therapeutic Innovation & Regulatory Science","year":2025,"doi":"10.1007/s43441-025-00846-3","pmid":"40711492","authors":"Mohd Sani N, Kasbon SH, Yap KY, et al.","paperType":"observational","findings":["Median total approval time for new active substances fell from 515 calendar days in 2017 to 399 in 2019, counting agency and applicant time together.","The median time between receipt of the dossier and the start of scientific assessment also fell.","Most indicators of good review practice were in place, including guidelines, standard operating procedures and review templates."],"whatItMeans":"This is the only measured approval time for Malaysia that OnCo found, and it covers all new medicines, not cancer medicines alone; it predates the faster reliance routes introduced from 2024.","caveats":["Data supplied by the agency itself, analysed with the Centre for Innovation in Regulatory Science.","Covers 24 products approved in 2019; not specific to cancer."],"participants":24},"route":"/key-papers/paper-mohd-sani-npra-approval-times-opera-tirs-2025/","neighbours":{"institution":[{"id":"npra-malaysia","kind":"institution","name":"National Pharmaceutical Regulatory Agency (NPRA), Malaysia","route":"/institutions/npra-malaysia/"}]}}