{"entity":{"id":"npra-malaysia","kind":"institution","name":"National Pharmaceutical Regulatory Agency (NPRA), Malaysia","aka":["NPRA","Bahagian Regulatori Farmasi Negara","Drug Control Authority","Pihak Berkuasa Kawalan Dadah","DCA Malaysia"],"tldr":"Malaysia's medicines regulator, part of the Ministry of Health. It evaluates new medicines for the Drug Control Authority in a target of 245 working days, and has shorter reliance routes for medicines already approved by named reference regulators.","summary":"The National Pharmaceutical Regulatory Agency, at Lot 36, Jalan Universiti, Petaling Jaya, evaluates medicines for registration by the Drug Control Authority under the Sale of Drugs Act 1952 and the Control of Drugs and Cosmetics Regulations 1984. Its Drug Registration Guidance Document (third edition, 12th revision, July 2026) gives an evaluation timeline of 245 working days for a new chemical entity, with consultation of local clinical specialists, and 210 for a hybrid product.\n\nIts Facilitated Registration Pathway, introduced by directive on 27 March 2019 with the EMA and US FDA as reference agencies, was revised from 1 January 2024: the reference agencies now also include Health Canada, Japan's PMDA, Swissmedic, Australia's TGA and the UK MHRA, the abbreviated review target fell from 120 to 90 working days, and a verification review for products assessed through the ASEAN Joint Assessment takes 30 working days. Malaysia joined the World Health Organization's collaborative registration procedures for prequalified products on 9 January 2020 and for products authorised by stringent authorities on 2 June 2022. A one-year pilot from 2 May 2026 adds a recognition route with a 60-working-day administrative timeline for products approved by the US FDA or through the EMA's centralised procedure, if submitted within three months of that approval.\n\nTwo studies by NPRA staff with the Centre for Innovation in Regulatory Science measured median approval times for new active substances of 515 calendar days in 2017 and 399 in 2019, agency and applicant time together. The coordinates are a Petaling Jaya centroid.","asOf":"2026-11-04","links":[{"label":"NPRA: DRGD Appendix 3, Guideline on Registration of New Drug Products (July 2026, PDF)","url":"https://npra.gov.my/~npraweb/easyarticles/images/users/1153/drgd_appendices/APPENDIX-3-Guidelines-on-Registration-of-New-Drug-Products.pdf"},{"label":"NPRA: Directive No. 13 of 2023 on the Facilitated Registration Pathway, Revision 1 (PDF, Malay and English)","url":"https://npra.gov.my/easyarticles/images/users/1051/Direktif--Guideline-FRP-Nov-2023.pdf"},{"label":"NPRA: New route under the Facilitated Registration Pathway, pilot from 2 May 2026","url":"https://npra.gov.my/index.php/en/component/content/article/225-english/1527850-new-route-under-the-facilitated-registration-pathway-frp-a-one-year-pilot-study-commencing-2-may-2026.html"},{"label":"Mohd Sani et al., approval times 2017 and 2019 (Ther Innov Regul Sci 2025)","url":"https://doi.org/10.1007/s43441-025-00846-3"},{"label":"National Pharmaceutical Regulatory Agency","url":"https://www.npra.gov.my"}],"tags":[],"related":[],"cancers":[],"sections":[],"technologies":[],"targets":[],"drugs":[],"companies":[],"institutions":["ministry-of-health-malaysia","mahtas-malaysia","clinical-research-malaysia"],"pathways":[],"terms":[],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-mohd-sani-npra-approval-times-opera-tirs-2025","paper-sani-npra-new-active-substances-2017-opera-tirs-2020"],"journals":[],"dependsOn":[],"notes":[],"city":"Petaling Jaya","country":"MY","lat":3.107,"lng":101.606,"institutionType":"government","website":"https://www.npra.gov.my","programs":["New drug registration: 245 working days (new chemical entity), 210 (hybrid)","Facilitated Registration Pathway: abbreviated review 90 working days, verification review 30","Recognition route pilot for US FDA and EMA approvals (60 working days, from 2 May 2026)","WHO collaborative registration procedures"]},"route":"/institutions/npra-malaysia/","neighbours":{"institution":[{"id":"clinical-research-malaysia","kind":"institution","name":"Clinical Research Malaysia","route":"/institutions/clinical-research-malaysia/"},{"id":"mahtas-malaysia","kind":"institution","name":"Malaysian Health Technology Assessment Section (MaHTAS)","route":"/institutions/mahtas-malaysia/"},{"id":"ministry-of-health-malaysia","kind":"institution","name":"Ministry of Health Malaysia","route":"/institutions/ministry-of-health-malaysia/"}],"paper":[{"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","route":"/key-papers/paper-sani-npra-new-active-substances-2017-opera-tirs-2020/"},{"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","route":"/key-papers/paper-mohd-sani-npra-approval-times-opera-tirs-2025/"}]}}