RHMI manages Malaysian drug registration end to end: assessing which NPRA route the product qualifies for (full evaluation, abbreviated review at 90 working days, verification at 30, or the FDA/EMA recognition pilot targeting 60), preparing the dossier for that route (ACTD conversion for standard routes; the sameness package for the recognition pilot), filing in QUEST3+ and managing NPRA queries through to the MAL number. The registration is filed under an independent holder, so the manufacturer keeps control of the asset it pays to create.
A note on terms: NPRA officially calls the holder the Product Registration Holder (PRH). Throughout RHMI's guides we use the equivalent international term, Marketing Authorisation Holder (MAH) - they mean the same party.
The first question: which route?
The single biggest driver of your Malaysian timeline is which review route your product qualifies for - and that depends on who has already approved it.
| Route | Target | Who qualifies |
|---|---|---|
| Verification review | 30 working days | Products with a positive ASEAN Joint Assessment outcome |
| Abbreviated review | 90 working days | Products approved by one recognised reference agency (EMA, US FDA, Swissmedic, UK MHRA, Health Canada, PMDA, TGA), filed within three years of that approval |
| Recognition pilot (FDA/EMA) | 60 working days | US FDA approvals, and EMA approvals via the centralised procedure (decentralised for generics only); filed within about three months of the reference approval, product identical to the approved one - a one-year pilot running since 2 May 2026 |
| Full evaluation | The longest route | Everyone else |
All review timelines are NPRA administrative targets, not guarantees: the clock runs from payment confirmation after screening acceptance and excludes the time you spend answering queries.
We start every engagement with this assessment, because filing on the wrong route - or missing a filing window - costs months. Which route does your region open?
What the service includes
- Route and eligibility assessment - including the reliance routes and their filing windows.
- Dossier preparation for the route. On the standard routes this means conversion from ICH CTD to the ASEAN Common Technical Document (ACTD): the science does not change, the structure does, and Malaysian-specific items are added. On the recognition pilot the submission instead relies on your approved FDA/EMA dossier - there the work is proving sameness with the approved product rather than restructuring, plus the Malaysian administrative part and local labelling that every filing needs.
- Local requirements - Malaysian labelling, a Certificate of Pharmaceutical Product (CPP), where applicable, in the form NPRA expects, site documentation, and stability data expectations for ASEAN Climate Zone IVb (hot and very humid - data generated for temperate markets is often not enough).
- Filing and query management - submission in QUEST3+, NPRA's registration system, and coordinated responses to NPRA queries - subject to timely input from your side, because slow query responses are one of the most common causes of delay.
- Through to the MAL number - and directly into the holder arrangements and import licensing that follow.
What we need from you
The approving regulator and approval date; the dossier as filed in your home market; GMP documentation for manufacturing and testing sites; and a decision-maker we can reach when NPRA asks questions. Everything else - conversion, local documents, filing mechanics - is our work.
After the MAL number
Registration is step one, not the finish line. The registration needs a holder who carries the ongoing obligations, and the product needs an import licence and GDP-compliant distribution before the first sale.
Discuss your product with us - or read how the next steps work: the independent holder and import & distribution.
Frequently asked questions
How long does drug registration take in Malaysia?
It depends on the route: verification review targets 30 working days, abbreviated review 90, the FDA/EMA recognition pilot 60, and full evaluation takes substantially longer. Add the time to prepare and convert the dossier before the clock starts.
Do we have to convert our dossier to ACTD?
On the standard routes, yes, unless it is already in ACTD format: Malaysia registers on the ASEAN Common Technical Document, most of the scientific content is reusable, the structure changes and Malaysian-specific items are added. On the FDA/EMA recognition pilot the submission relies on the approved dossier instead.
Can you file if our product is not approved anywhere yet?
The realistic route for an unapproved product is full evaluation. We take these case by case - and tell you honestly whether the timeline and cost are worth it before you commit.
Who holds the registration after approval?
A locally incorporated entity must. With RHMI the registration sits with an independent holder, and your ownership of the dossier and transfer rights are fixed by contract.
You might also find useful
- Drug Registration in Malaysia: Process, Timeline and Requirements
- Fast-Track Registration: Register Your FDA/EMA-Approved Drug Faster in Malaysia
- CTD to ACTD: Mapping Your Dossier for Malaysia
- Editorial note: This page describes RHMI's registration service. Regulatory timelines, fees and eligibility are administrative details that change; we confirm them against NPRA's current guidance in every engagement. Last reviewed: 1 September 2026.