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Thai FDA

Medicines and herbal products registration

Imported modern medicines are registered under the Drug Act B.E. 2510; products with herbs as key ingredients fall under the Herbal Products Act B.E. 2562, with three routes by risk: notification, detailed notification or full registration. Every key step of our drug and herbal work is reviewed and signed off by a pharmacist.

Typical time From about 2 months (herbal) to 12+ months (new drugs) Government cost By route and product
Classify and choose route→Licence and dossier→Pharmacist review and filing
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How the work runs

The five stages, end to end

11–2 weeksClassification and routeCompany + pharmacist2About 1–2 monthsPremises licenceThai FDA31–3 monthsDossier and GMPManufacturer + company4Set by Thai FDAPharmacist review andfilingPharmacist + Thai FDA
Durations are planning estimates for files with complete factory documents.
  1. 1

    Classification and route

    Handled by: Company + pharmacist · Time: 1–2 weeks

    Drug or herbal product; for herbal products, notification, detailed notification or registration depending on complexity and how serious the indication is.

  2. 2

    Premises licence

    Handled by: Thai FDA · Time: About 1–2 months

    Licence to import medicines (with a responsible pharmacist and storage) or herbal products.

  3. 3

    Dossier and GMP

    Handled by: Manufacturer + company · Time: 1–3 months

    Herbal formula and evidence of use; for medicines, the foreign manufacturer's GMP clearance and an ASEAN CTD dossier.

  4. 4

    Pharmacist review and filing

    Handled by: Pharmacist + Thai FDA · Time: Set by Thai FDA

    A pharmacist signs off the dossier before submission; Thai FDA review time depends on the route.

Costs

ItemAmountSource
Thai FDA consideration feesBy route (MOPH fee notifications)Official rate
Registration service with pharmacist reviewQuoted per product and routePUNNAKA quotation
Treatment claims decide the route: a herbal product claiming to treat a serious disease needs full registration, while a food supplement cannot claim to treat anything. We check claims before choosing the route.

Other categories

Thai FDASkincare and cosmeticsAbout 1–2 monthsThai FDAFood and snacksAbout 2–4 monthsThai FDADietary supplementsSet after assessmentThai FDAMedical devicesAbout 2–9 monthsTISIElectrical appliancesAbout 4–6 monthsTISIToys and kids productsSet after assessmentOperationsFreight transport1–3 days in ThailandOperationsCompany registration and addressAbout 2–4 weeksOperationsWarehousing and storageReady in about 1 weekOperationsImport and export logisticsAbout 1–2 weeks per shipmentOperationsThai label inspection2–5 working daysOperationsRetail and marketplace placementAbout 2–8 weeks

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