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Regulatory pathways · Entering from abroad

Bringing a foreign pharmaceutical product into Malaysia

You are a foreign manufacturer or brand owner with no Malaysian entity yet.

This applies whatever you register.

Entry from abroad is not a separate route — it is a requirement laid over every product door: a Malaysian holder, recognised GMP, and an import licence. Pick the product you are bringing, then read its route:

Generic medicines
You make or import an off-patent molecule — a generic of an already-registered drug.
New / innovator drugs
You are bringing a new chemical entity — never registered here — to the Malaysian market.
Biologics & biosimilars
You are registering a biologic new to Malaysia, or a biosimilar of a reference product.
Health supplements
You are launching a vitamin, mineral or nutraceutical health supplement.
Traditional & herbal
You are registering a traditional medicine or herbal product.
Where it gets hard
The register makes the pathway legible. These parts don't self-serve.
  • Appointing a Malaysian product-registration holder / local representative
  • PIC/S GMP recognition for your manufacturing site
  • The importer / wholesaler licence and post-market obligations
Talk to our consultantsWe run the dossier, the GMP path and the holder appointment with you.