Manufacturers filing from within ASEAN have a structural advantage: ACTD is already the dossier format, so no conversion is needed. Filing from Japan, Korea, Taiwan, India or China in ICH CTD format requires restructuring. But you still cannot hold the registration yourself - a locally incorporated Marketing Authorisation Holder (MAH) is required. Of NPRA's seven reference agencies only PMDA Japan is Asian; ASEAN Joint Assessment and WHO outcomes are also accepted. PIC/S participation helps your GMP file but is not a registration shortcut.
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.
If you manufacture within ASEAN, you start with an advantage no European or American competitor has: the dossier format is already right. Malaysia uses the ASEAN Common Technical Document (ACTD), so an ASEAN filing needs no conversion. Filing from Japan, Korea, Taiwan, India or China in ICH CTD format is a different matter - there the dossier must be restructured. Either way you need what everyone needs: a locally incorporated holder.
ACTD is already your format
For manufacturers in Indonesia, Thailand, Vietnam, the Philippines or Singapore, the ACTD structure is familiar and largely transferable. Parts I to IV carry administrative, quality, non-clinical and clinical content respectively. Country-specific work remains - Malaysian labelling, a Certificate of Pharmaceutical Product, and site documentation - but you are not rebuilding the dossier. For manufacturers filing from Japan, Korea, Taiwan, India or China in ICH CTD format, a conversion is required. The registration process in full.
Which Asian approvals open a reliance route
Of NPRA's seven recognised reference agencies, exactly one is Asian: PMDA Japan. Separately, NPRA accepts ASEAN Joint Assessment decisions and WHO stringent regulatory authority or prequalification outcomes.
| Filing from | Reliance route | Practical consequence |
|---|---|---|
| Japan (PMDA approval) | General FRP - recognised reference agency | Abbreviated or verification review available |
| ASEAN member states | ASEAN Joint Assessment where applicable | ACTD already native; no conversion |
| Korea, Taiwan, Singapore, Thailand, Indonesia | PIC/S participation supports GMP recognition | GMP position is strong; product reliance is not automatic |
| India, China | No reliance route | Full evaluation unless a WHO PQ or recognised-agency approval exists |
The honest summary: PIC/S participation helps your GMP file, but it is not a registration shortcut. Only a recognised agency approval, ASEAN Joint Assessment or WHO outcome shortens the review itself.
Manufacturers in India and China: what we require
RHMI works with Indian and Chinese manufacturers on a specific condition - the manufacturing site must hold EU GMP or US FDA certification. This is not a regulatory rule of NPRA's; it is our own commercial standard, and we apply it because it is what makes a product defensible with Malaysian buyers and institutions. If your site holds EU GMP or FDA approval, the conversation is straightforward. If it does not, we are not the right partner.
The Certificate of Pharmaceutical Product (CoPP)
A CoPP issued by your national authority in the WHO format is a standard requirement in the Malaysian submission. It confirms that the product is authorised in the country of origin and that the manufacturing site is subject to GMP inspection. Two practical points: the certificate must be current and properly authenticated where required, and if your product is not registered in your home country - a common situation for export-only manufacturers - you need to resolve that before you can file, because a CoPP for an unregistered product is either unavailable or heavily qualified.
You still need a Malaysian holder
Being in the same region does not change the core requirement: the registration must be held by a locally incorporated Malaysian entity. Exporters commonly discover this only after finding a buyer, and default to letting that buyer hold the registration - which converts a customer into a gatekeeper. What an MAH does and why the distributor-as-holder shortcut is risky.
After registration: importing and distributing
Registration is step one. The importing entity needs its own licence, and distribution runs under GDP. If your plan is to supply an existing Malaysian distributor, these are the mechanics that follow: import licences and GDP, and how the Malaysian distributor landscape is structured.
Frequently asked questions
Can I export pharmaceuticals to Malaysia without a local company?
You can export, but the product cannot be registered or sold unless a locally incorporated Malaysian entity holds the product registration. A foreign exporter appoints a local Marketing Authorisation Holder - its buyer, its own subsidiary, or an independent MAH.
Do I need to convert my dossier to ACTD for Malaysia?
If you are filing from an ASEAN country, the ACTD format is already what you use and no conversion is needed. If you are filing from Japan, Korea, Taiwan, India or China in ICH CTD format, the dossier must be reorganised into ACTD Parts I to IV, with Malaysian labelling and a Certificate of Pharmaceutical Product added.
Does PIC/S membership fast-track registration in Malaysia?
No. PIC/S participation supports recognition of your GMP status, which strengthens the quality part of your file. It does not shorten the registration review. Only an approval from a recognised reference agency, an ASEAN Joint Assessment decision or a WHO outcome opens a reliance route.
Which Asian regulator is recognised by NPRA?
PMDA Japan is the only Asian agency among NPRA's seven recognised reference agencies. NPRA additionally accepts ASEAN Joint Assessment decisions and WHO prequalification or stringent regulatory authority assessments.
You might also find useful
- Drug Registration in Malaysia: Process, Timeline and Requirements
- Importing and Distributing Pharmaceuticals in Malaysia: Licences and GDP
- Pharmaceutical Distributors in Malaysia: Top Companies and How to Choose
- 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.