No Latin American regulator is among NPRA's recognised reference agencies, so an ANVISA, ANMAT, INVIMA or COFEPRIS approval does not shorten a Malaysian review - expect full evaluation. What does help: ANVISA (2021), ANMAT Argentina (2008) and COFEPRIS Mexico (2018) are PIC/S participating authorities, as is Malaysia, which supports the GMP part of your file - subject to NPRA review. A WHO prequalification or an approval from a recognised agency does open a reliance route. You will still need a locally incorporated Marketing Authorisation Holder (MAH).
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.
This page exists to answer one question honestly, because nobody else does: does your ANVISA, ANMAT, INVIMA or COFEPRIS approval shorten a Malaysian registration? No. Your GMP standing helps. Your approval does not shorten the review.
GMP recognised, review speed not
These two things get conflated constantly, and the distinction decides your timeline:
| Status | What it means for you | |
|---|---|---|
| GMP standing | Supported for some countries - ANVISA (2021), ANMAT Argentina (2008) and COFEPRIS Mexico (2018) are PIC/S participating authorities, as is Malaysia | Your quality and site documentation starts from a credible position, subject to NPRA review |
| Product reliance | Not available - no Latin American regulator is among NPRA's recognised reference agencies | Expect a full evaluation, not an abbreviated or verification review |
NPRA's recognised agencies are EMA, US FDA, Swissmedic, UK MHRA, Health Canada, PMDA and TGA, plus ASEAN Joint Assessment and WHO outcomes. NPRA has described its current recognition pilot as a test before extending the approach to further agencies - so the accurate framing is not yet, rather than never.
The route that does exist
Two practical paths are open to a Latin American manufacturer:
- WHO prequalification. If your product is WHO prequalified, that outcome is accepted by NPRA and does open a reliance route. For manufacturers of essential medicines and generics this is often the most realistic shortcut.
- An approval from a recognised agency. If the same product is also approved by, for example, the EMA or US FDA, that approval - not your domestic one - is what you rely on.
Absent either, plan for full evaluation and build the timeline accordingly. The registration process and requirements.
By country
| Country | Regulator | Position |
|---|---|---|
| Brazil | ANVISA | PIC/S participating authority since 2021 - strong GMP position, no reliance route |
| Argentina | ANMAT | PIC/S participating authority since 2008 - supports GMP; no reliance route |
| Colombia | INVIMA | PAHO-recognised regionally; not a PIC/S participating authority; not an NPRA reference agency |
| Mexico | COFEPRIS | PIC/S participating authority since 2018 - supports GMP; not an NPRA reference agency |
| Chile | ISP | Not a PIC/S participating authority; not an NPRA reference agency |
You still need a Malaysian holder
As for every foreign manufacturer, the Malaysian registration must be held by a locally incorporated entity. RHMI can act as that holder without you incorporating in Malaysia and without your registration sitting in a distributor's name - what that role involves, and why the distributor shortcut carries lock-in risk.
Is Malaysia worth it for a Latin American manufacturer?
Honestly: only for a specific profile. If you produce generics or specialty products at competitive cost, hold PIC/S-aligned GMP, and are looking for an English-language ASEAN entry point with a predictable regulator, Malaysia is a credible target. If you are looking for a fast, low-cost registration on the strength of your domestic approval, this is not that market. We would rather tell you before you spend the money. See what the fast-track routes require.
Frequently asked questions
Does an ANVISA approval fast-track registration in Malaysia?
No. ANVISA is not among NPRA's recognised reference agencies, so a Brazilian approval does not open an abbreviated or verification review. ANVISA has been a PIC/S participating authority since January 2021, which supports the GMP part of your file, but GMP standing and review speed are separate things.
Are any Latin American regulators recognised by NPRA?
No. NPRA's recognised reference agencies are EMA, US FDA, Swissmedic, UK MHRA, Health Canada, PMDA Japan and TGA Australia. NPRA also accepts ASEAN Joint Assessment decisions and WHO outcomes. No Latin American regulator is currently included.
Is there any faster route for a Latin American manufacturer?
Yes, indirectly. WHO prequalification is accepted by NPRA and does open a reliance route. So does an approval of the same product by a recognised agency such as the EMA or US FDA. Without one of those, expect a full evaluation.
Can a Brazilian or Argentinian company hold a Malaysian registration?
No. The holder must be a locally incorporated Malaysian entity. A Latin American manufacturer appoints a local Marketing Authorisation Holder - a distributor, its own subsidiary, or an independent MAH.
You might also find useful
- Drug Registration in Malaysia: Process, Timeline and Requirements
- Marketing Authorisation Holder (MAH) in Malaysia: What It Is and How to Appoint One
- Fast-Track Registration: Register Your FDA/EMA-Approved Drug Faster in Malaysia
- Sources:
- NPRA Drug Registration Guidance Document (DRGD): npra.gov.my (DRGD)
- PIC/S - List of Participating Authorities (accession dates): picscheme.org
- RAPS - Malaysia's NPRA updates regulatory reliance guide, expands pool of reference agencies: raps.org
- NPRA - New Route under the Facilitated Registration Pathway (FRP), one-year pilot from 2 May 2026: npra.gov.my
- Editorial note: This page is general business and regulatory information for manufacturers evaluating Malaysia. It is not legal or regulatory advice. Timelines, fees and eligibility are administrative details that change; confirm them against NPRA's current guidance before acting. Last reviewed against NPRA guidance: 15 August 2026.