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March 7, 2026
Approximately 5 minutes
Frequently Asked Questions on Pharmaceutical and Veterinary Drug Registration by Thailand FDA
Frequently Asked Questions on Pharmaceutical and Veterinary Drug Registration by Thailand FDA
Overview
The Thailand Food and Drug Administration (FDA) provides answers to common questions on drug registration processes. This includes requirements for human drugs (vaccines and biological products) and detailed guidance on veterinary drug registration categories, forms, procedures, timelines, and fees. All drugs must comply with the Drugs Act B.E. 2510 (1967) and related notifications. Last updated information references manuals and notifications from 2008–2021. Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Issues Relating to Drug Registration
Q2: Format of the Certificate of Pharmaceutical Product (CPP) for vaccine and biological product registration
Refer to the CPP examples in the Manual/Rules for the Registration of Biological Products for Human Use in Accordance with ASEAN Harmonization, issued under the Notification of the Food and Drug Administration Re: Drug Registration under the Agreement on the ASEAN Harmonization Product on Pharmaceutical Registration (B.E. 2551 (2008)), and the Notification of the Food and Drug Administration Re: Implementation of the ASEAN Harmonized Product on Pharmaceutical Registration (No.2), B.E. 2564 (2021). Link: https://drive.google.com/file/d/1It4OVWuCHpL1NSLoK2Bu3hqMCTwoiy7T/view?usp=sharing Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Q3: Special channel and procedures for COVID-19-related drug registration
Learn procedures from the Notifications of the Food and Drug Administration Re: Conditional Approval of Modern Pharmaceutical Products for Human Use in Pandemic Emergency Situations. Links:
- https://drive.google.com/file/d/1hu_hEs97RtZMBMuNCv2ymo1BBnByHw7F/view?usp=sharing
- https://drive.google.com/file/d/1r7lQhRwshFCoeaFrdOupzrOP5pi3Xt2T/view?usp=sharing
- https://drive.google.com/file/d/1NrVTD0lxmVk8Eq4FPC_w39hITKKiTWSV/view?usp=sharing Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Issues Relating to Registration of Modern Veterinary Drugs
Q4: Categories of veterinary drug registration
Registration is divided into two main categories: modern drugs and traditional drugs. Modern veterinary drugs are subdivided into chemical drugs and biological products or vaccines. Traditional veterinary drugs are subdivided into traditional drugs and developed herbal drugs. Details are in public manuals on the “Public Manual Information Center” website at https://www.info.go.th. Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Q5: Download application forms for veterinary drug registration
Forms and documents are available on the “Public Manual Information Center” website at https://www.info.go.th. Search using keywords like “veterinary drugs” or “drug registration.” Select the relevant manual and then “8. Forms, Examples and Manuals for Filling in the Forms.” Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Q6: Processing time for veterinary drug registration
Time depends on the drug category. Public manuals specify procedures and timelines under “4. Procedures, Time and Responsible Division.” Examples: modern chemical generic drug – 120 business days; modern chemical new drug – 220 business days (assuming complete documents). Additional explanations may extend timelines. Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Q7: Fees for veterinary drug registration
Fees follow the Notification of the Ministry of Public Health Re: Fees Collectable from Applicants in the Drug Approval Process. They vary by category and include application/dossier screening validation fee, technical document evaluation fee, and certificate of registration fee. Examples in the table below (full details in public manuals under “6. Fees”):
| Drug Categories | Application/Dossier Screening Validation Fee | Technical Document Evaluation Fee | Certificate of Registration Fee |
|---|---|---|---|
| Modern chemical drug (generic drug) | 1,000 Thai Baht | 49,000 Thai Baht | 2,000 Thai Baht |
| Modern chemical drug (new drug) | 2,500 Thai Baht | 182,500 Thai Baht (NCE) or 155,000 Thai Baht (non-NCE) | 2,000 Thai Baht |
| Modern drug (vaccine) | 1,000 Thai Baht | 123,000 Thai Baht | 2,000 Thai Baht |
Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Q8: Procedures for veterinary drug registration
Procedures for modern veterinary drugs include pre-registration and registration steps:
-
Domestic manufacturing (licensed manufacturer):
- Step 1: Apply for license to manufacture drug sample (Form Por.Yor.8).
- Step 2: Apply for drug registration (Form Yor.1) with sample, technical documents, and evidence.
-
Importation/ordering (licensed importer):
- Step 1: GMP Clearance for overseas manufacturers.
- Step 2: Apply for license to import/order sample (Form Nor.Yor.8).
- Step 3: Apply for drug registration (Form Yor.1) with sample, technical documents, and evidence.
Detailed steps in public manuals. Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
Contact and Additional Resources
Contact the FDA for specific queries. Public manuals and forms available at https://www.info.go.th. No standalone DMF FAQ section; refer to related registration services. Source: https://en.fda.moph.go.th/our-services-new/category/cat2-frequently-asked-questions
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