{"entity":{"id":"paper-sani-npra-new-active-substances-2017-opera-tirs-2020","kind":"paper","name":"An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology","aka":[],"tldr":"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.","summary":"Using the OpERA tool, the authors collected milestone data for the 25 new active substances and 1 biosimilar approved by NPRA in 2017 to see where time was spent and to set a baseline for improvement.","asOf":"2026-11-04","links":[{"label":"Ther Innov Regul Sci 2020","url":"https://doi.org/10.1007/s43441-020-00140-4"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/32865804/"}],"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":2020,"doi":"10.1007/s43441-020-00140-4","pmid":"32865804","authors":"Sani NM, McAuslane N, Kasbon SH, et al.","paperType":"observational","findings":["Median approval time 515 days, agency and applicant time together.","Median time from dossier receipt to the start of scientific assessment 135 days, with wide variation in queuing.","Median assessment time 279 days: NPRA a median of 166 days and applicants 131 days to respond to questions; up to 6 review cycles, with 65% of applications needing 4 to 5.","NPRA proposed starting scientific assessment within 100 days of file acceptance, a maximum of 5 review cycles and a 6-month limit on applicant responses."],"whatItMeans":"It explains why the 245-working-day target and the measured time differ: much of the elapsed time was queuing before review and rounds of questions to the applicant.","caveats":["One year of approvals, 26 products; not specific to cancer."],"participants":26},"route":"/key-papers/paper-sani-npra-new-active-substances-2017-opera-tirs-2020/","neighbours":{"institution":[{"id":"npra-malaysia","kind":"institution","name":"National Pharmaceutical Regulatory Agency (NPRA), Malaysia","route":"/institutions/npra-malaysia/"}]}}