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March 7, 2026
Approximately 5 minutes
Thailand FDA Pharmaceutical Product Registration and Approval Process
Thailand FDA Pharmaceutical Product Registration and Approval Process
Overview
All drugs manufactured, imported, or ordered into Thailand are regulated by the Food and Drug Administration (FDA). Finished pharmaceutical products for human or animal use must be registered with the FDA prior to manufacturing, importation, or ordering. Approved persons must comply with rules for drug facilities, best practices, Good Manufacturing Practice (GMP), pharmaceutical quality management, and distribution conditions. Specific provisions under sections 13 and 79 bis of the Drugs Act B.E. 2510 (1967) and amendments apply for importation of drugs for clinical studies, exhibitions, donations, etc. Last updated: 29 March 2023. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
Types of Pharmaceutical Products and Registration Requirements
Finished Pharmaceutical Products (General Sale)
Finished products for human or animal use require registration with the FDA before manufacturing, importation, or ordering. Special procedures include manufacturing lot approval: human vaccines and plasma-derived products require a Certificate of Lot Release from the Department of Medical Sciences before distribution; veterinary vaccines require a Certificate of Lot Release from the FDA. Drugs listed in the Ministry of Commerce Notification require FDA approval before importation permission. Documents and standards: prepare per ASEAN Common Technical Dossier (ACTD) or ICH Common Technical Document (ICH CTD). Registration forms vary by risk (e.g., new drugs, new biological products). Consultation with Medicines Regulation Division available. Fees charged for approval. Active Pharmaceutical Ingredients (APIs): raw materials that are active ingredients must be notified to the FDA prior to manufacturing, importation, or ordering. Facilities must meet FDA-approved standards like GMP. Notification fees for pharmaceutical chemicals charged. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
Pharmaceutical Products for Specific Purposes
Drugs may be manufactured or imported as samples for registration, for clinical trials involving human subjects, for analysis, for donation to healthcare facilities, or for exhibitions. Specific steps, rules, procedures, and conditions outlined in relevant Notifications for each purpose. Emergency use conditions detailed in separate PDFs. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
Application for Certification/Approval Prior to Importation
Certificates required: human vaccines, plasma-derived products, and biological products (per Notification) require Certificate of Lot Release from Institute of Biological Products, Department of Medical Sciences. Veterinary vaccines require Certificate of Lot Release from FDA. Drugs potentially misused or under strict restrictions (per Ministry of Commerce Notification) require approval document from FDA prior to importation. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
Post-Approval Obligations
Approved persons must comply with drug facility rules, best practices, GMP, pharmaceutical quality management, and distribution conditions as prescribed in laws and registration conditions. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
Additional Information
Consultation: Contact Medicines Regulation Division for document preparation facilitation. Fees: charged for drug registration approvals and pharmaceutical chemical notifications. Legal references: Sections 13 and 79 bis of the Drugs Act B.E. 2510 (1967) and amendments. Certificate of Lot Release details available. No specific timelines, detailed application steps, or separate guidelines for new drugs, generics, biologics are detailed beyond general registration variations by risk and document preparation per ACTD/ICH CTD. Contact via https://en.fda.moph.go.th/home-contact-us/. Source: https://en.fda.moph.go.th/our-services-new/our-services-pharmaceutical-product-registration-and-approval
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