Regulatory pathways · Traditional & herbal

Registering a traditional or herbal product in Malaysia

You are registering a traditional medicine or herbal product.

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
Traditional product registration
Generic · small molecule · traditional
RM5,000 processing + RM20,000 GMP inspection (foreign site) where applicable
612 months
Traditional product registration (new formulation)
New · small molecule · traditional
RM5,000 processing + RM20,000 GMP inspection (foreign site) where applicable
915 months
What the pathway asks.
  • Traditional-use / literature safety dossier
  • GMP certification (traditional)
  • Local product registration holder
  • Safety & quality dossier
  • Substantiation of claims
Where it gets hard
The register makes the pathway legible. These parts don't self-serve.
  • Safety and heavy-metal / microbial limits testing
  • Traditional-use justification for the formulation
  • GMP for traditional-product manufacture
Talk to our consultantsWe run the dossier, the GMP path and the holder appointment with you.