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Regulatory pathways · Generic medicines

Registering a generic medicine in Malaysia

You make or import an off-patent molecule — a generic of an already-registered drug.

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.
012mo24mo
Abridged (non-prescription) evaluation
Generic · small molecule · non-prescription
RM5,000 processing + RM20,000 GMP inspection (foreign site)
9–15 months
Abridged / generic evaluation
Generic · small molecule · prescription
RM5,000 processing + RM20,000 GMP inspection (foreign site)
12–18 months
What the pathway asks.
  • Bioequivalence or bioavailability data
  • PIC/S GMP certification
  • Local product registration holder
  • Bioequivalence study
Where it gets hard
The register makes the pathway legible. These parts don't self-serve.
  • Bioequivalence (BE) study design and a compliant BE report
  • A CTD dossier that survives abridged evaluation queries
  • Appointing a Malaysian product-registration holder
Talk to our consultantsWe run the dossier, the GMP path and the holder appointment with you.