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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.
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.
Its 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.
Two 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.
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.
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.
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