# An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology

Source: https://onco.cc/key-papers/paper-sani-npra-new-active-substances-2017-opera-tirs-2020/  
OnCo record `paper-sani-npra-new-active-substances-2017-opera-tirs-2020` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: Therapeutic Innovation & Regulatory Science
- Year: 2020
- DOI: 10.1007/s43441-020-00140-4
- Authors: Sani NM, McAuslane N, Kasbon SH, et al.
- 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.
- What it means: 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.

## Sources

- Ther Innov Regul Sci 2020: https://doi.org/10.1007/s43441-020-00140-4
- PubMed: https://pubmed.ncbi.nlm.nih.gov/32865804/

## Connected records

- institutions: [National Pharmaceutical Regulatory Agency (NPRA), Malaysia](https://onco.cc/institutions/npra-malaysia/)

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