Registering a new drug in Malaysia

You are bringing a new chemical entity — never registered here — to the Malaysian market.

Your route into Malaysia.

The DRGD door(s) for this product class, on the same month axis the register uses — how long each takes and what it asks. Neutral facts; the timing call for a specific molecule is the read.

012mo24mo36mo

Full (new drug) non-prescription evaluation

New · small molecule · non-prescription

RM5,000 processing + RM20,000 GMP inspection (foreign site)

15–24 months

Full (new drug) evaluation

New · small molecule · prescription

RM5,000 processing + RM20,000 GMP inspection (foreign site)

18–30 months

What the pathway asks.

Full quality/safety/efficacy dossier
PIC/S GMP certification
Local product registration holder

Where it gets hard

The register makes the pathway legible. These parts don't self-serve.

A full-evaluation CTD dossier (Modules 1–5) with clinical data
Certificate of Pharmaceutical Product (CPP) from a reference country
PIC/S GMP evidence for every foreign manufacturing site

Talk to our consultantsWe run the dossier, the GMP path and the holder appointment with you.