All government fees below are confirmed from the Ministerial Regulation on Drug Fees B.E. 2566 (2023 CE) and the MoPH Notification on Costs Collectable from Applicants B.E. 2568 (2025 CE), as amended by Notification No. 2, B.E. 2569 (2026 CE). These are fees paid directly to Thai FDA. They do not include professional service fees, dossier preparation costs, or translation expenses.
Thai FDA government costs for drug registration draw from two separate official instruments. Understanding their relationship prevents confusion when totalling what a registration will cost.
Sets the statutory fees payable to the government: the certificate of drug registration fee, operating licence fees, and renewal fees. These are fixed amounts under the Drug Act B.E. 2510. The current regulation superseded Ministerial Regulation No. 26 (B.E. 2537). For a modern drug registration certificate, the statutory certificate fee is 2,000 THB.
Sets the costs collected from applicants to cover document review, administrative processing, and technical assessment. These are charges for the government's review work, not statutory licence fees. The notification was published in the Royal Gazette on 30 December B.E. 2568 (2025 CE) and came into force the following day, superseding the B.E. 2566 version. It was amended by Notification No. 2, B.E. 2569, in force from 20 June 2026. For most registration processes, total government cost = Schedule 1 administrative fee + Schedule 2 technical assessment fee + statutory certificate fee from the Ministerial Regulation.
The amounts on this page are fees paid to Thai FDA. They do not include the cost of preparing the dossier, translating documents, conducting bioequivalence studies, appointing a local holder, or any professional regulatory service. For a full cost model, contact us.
Each registration application involves three government cost components: the Schedule 1 administrative application fee, the Schedule 2 technical assessment fee, and the statutory certificate fee under the Ministerial Regulation. Totals below are the sum of all three.
| Drug Type | Admin Fee (THB) | Technical Assessment (THB) | Certificate (THB) | Total (THB) |
|---|---|---|---|---|
| New Chemical Entity (NCE) or New Biological Entity (NBE) | 2,500 | 182,500 | 2,000 | 187,000 |
| NCE / NBE — first registered in Thailand for ASEAN regional disease | 2,500 | 395,000 | 2,000 | 399,500 |
| New Drug — non-NCE/NBE (new indication, form, route, or strength) | 2,500 | 155,000 | 2,000 | 159,500 |
| Human Vaccine (biological) | 2,500 | 182,500 | 2,000 | 187,000 |
| Biosimilar | 1,000 | 196,500 | 2,000 | 199,500 |
| Standard biological — not a new biological entity | 1,000 | 123,000 | 2,000 | 126,000 |
| Drug Type | Admin Fee (THB) | Technical Assessment (THB) | Certificate (THB) | Total (THB) |
|---|---|---|---|---|
| Generic Drug — specification or method not matching the official pharmacopoeia | 1,000 | 59,000 | 2,000 | 62,000 |
| Generic Drug — specification and method matching the official pharmacopoeia | 1,000 | 39,000 | 2,000 | 42,000 |
| New trade name — same data as already-registered new drug or NBE | 2,500 | 15,000 | 2,000 | 19,500 |
| New trade name — same data as already-registered non-new drug | 1,000 | 8,000 | 2,000 | 11,000 |
| Re-registration of cancelled or lapsed registration | 1,000 | — | 2,000 | 3,000 |
| Export-only drug registration | 500 | — | 2,000 | 2,500 |
What decides the generic rate: the two generic rows are separated solely by whether the product's specification and analytical method conform to the pharmacopoeia the Minister of Public Health has announced, or a later edition of it. Conforming products are assessed at 39,000 THB (Schedule 2 item 1.4); non-conforming products require the fuller assessment at 59,000 THB (item 1.3). Whether a bioequivalence study or waiver is involved does not affect which rate applies.
Re-registration and export-only: No Schedule 2 technical assessment fee was listed for these categories in the confirmed source documents. Confirm directly with Thai FDA before submitting.
Replacement certificate: A replacement certificate of drug registration (ใบแทนใบสำคัญการขึ้นทะเบียนตำรับยาแผนปัจจุบัน) costs 100 THB per copy.
Drug reclassification: Technical assessment for a product reclassification (เปลี่ยนประเภทยา) is 99,000 THB per product.
Variation applications are classified as major (ระดับหลัก), minor (ระดับรอง), or administrative/OSSC. Total government cost = Schedule 1 application fee + Schedule 2 technical assessment fee. No certificate fee applies to variation submissions. The MaV and MiV classification follows the Thai FDA announcement on documents and evidence for varying drug registration particulars, dated 28 September B.E. 2566, and its subsequent amendments.
Merger relief. Under Notification No. 2, B.E. 2569, in force from 20 June 2026, a company reorganisation that changes only the licence holder's particulars across multiple registrations may be filed as a single minor variation application covering several registrations. This covers amendments to the registration certificate, labels, or package inserts that involve no assessment of quality, efficacy, or safety. Only Schedule 1 costs are charged in that case, with no Schedule 2 technical assessment fee. This is a material saving on an acquisition involving a large registered portfolio.
| Variation Category | Drug Type | Application Fee (THB) | Technical Assessment (THB) | Total (THB) |
|---|---|---|---|---|
| MaV-1 | New drug, biologic, herbal modern drug, or vaccine | 800 | 43,500 | 44,300 |
| MaV-2 | New drug, biologic, herbal modern drug, or vaccine | 800 | 22,500 | 23,300 |
| MaV-1 — different from reference drug | Non-new, non-biologic drug | 800 | 43,500 | 44,300 |
| MaV-1 — same as reference drug | Non-new, non-biologic drug | 800 | 6,500 | 7,300 |
| MaV-2 | Non-new, non-biologic drug | 800 | 6,500 | 7,300 |
| MaV-4 and MaV-5 | New drug, biologic, herbal modern drug, or vaccine | 800 | 21,500 | 22,300 |
| MaV-4 and MaV-5 | Non-new, non-biologic drug | 800 | 16,500 | 17,300 |
| MaV-3 and MaV-6 through MaV-16 | New drug, biologic, herbal modern drug, or vaccine | 800 | 16,500 | 17,300 |
| MaV-3 and MaV-6 through MaV-16 | Non-new, non-biologic drug | 800 | 11,500 | 12,300 |
| Any variation Thai FDA classifies as major (outside the above) | All types | 800 | 16,500 | 17,300 |
| Variation Type | Expert Review Required | Application Fee (THB) | Technical Assessment (THB) | Total (THB) |
|---|---|---|---|---|
| Minor — MiV-PA-1 through MiV-PA-36 | Yes | 500 | 8,800 | 9,300 |
| Minor — MiV-PA-1 through MiV-PA-36 | No | 500 | 1,800 | 2,300 |
| Minor — any variation Thai FDA classifies as minor (outside the above) | Yes | 500 | 8,800 | 9,300 |
| Minor — any variation Thai FDA classifies as minor (outside the above) | No | 500 | 1,800 | 2,300 |
| Administrative / OSSC variation (one-stop-service centre) | — | 300 | — | 300 |
Under the Drug Act as amended B.E. 2562 (2019 CE), marketing authorizations issued after the amendment date are valid for 7 years. Under Clause 3 of the Ministerial Regulation on Renewal of Drug Formula Registration Certificates B.E. 2566, renewal must be filed within the 1-year window before expiry; section 86/2 of the Act allows a late application up to 1 month after expiry with a written justification, after which renewal is no longer possible. Certificates issued before the 2562 amendment took effect run on a transitional schedule of 5, 7, or 9 years depending on when the product was first registered. Operating licences expire on 31 December each year and must be renewed annually.
| Item | Fee (THB) | Basis |
|---|---|---|
| Renewal statutory fee — modern drug registration certificate | 1,000 | Half the 2,000 THB certificate fee under item (16) of the Ministerial Regulation on Drug Fees B.E. 2566 |
| Renewal application processing cost | 1,000 | Schedule 1 item 4.5, which lists the application to renew a drug registration certificate among the other applications related to authorisation |
| Technical assessment cost for renewal (where applicable) | Varies | Equal to the applicable Schedule 2 assessment rate for the licence type being renewed; determined by Thai FDA on a case-by-case basis |
| Licence | Annual Fee (THB) | Notes |
|---|---|---|
| Drug Import Licence (ใบอนุญาตนำหรือสั่งยาแผนปัจจุบันเข้ามาในราชอาณาจักร) | 10,500 | 10,000 statutory licence fee + 500 application processing cost; expires 31 December annually |
| Drug Manufacturing Licence (ใบอนุญาตผลิตยาแผนปัจจุบัน) | 8,500 | 8,000 statutory licence fee + 500 application processing cost; applies to Thailand-based manufacturers only |
| Drug Selling Licence — Retail (ใบอนุญาตขายยาแผนปัจจุบัน) | 2,500 | 2,000 statutory licence fee + 500 application processing cost |
| Drug Selling Licence — Wholesale (ใบอนุญาตขายส่งยาแผนปัจจุบัน) | 2,000 | 1,500 statutory licence fee + 500 application processing cost |
Licence renewal fee: Under item (15) of the Ministerial Regulation, the renewal fee for any operating licence equals half the licence fee for that type. Drug import licence renewal statutory fee: 5,000 THB. Manufacturing licence renewal statutory fee: 4,000 THB. Application processing cost is additional in each case.
Replacement licence: A replacement licence (ใบแทนใบอนุญาต) costs 100 THB per copy under the Ministerial Regulation.
Any drug advertisement requires Thai FDA pre-approval before dissemination under Sections 88 and related provisions of the Drug Act B.E. 2510. Two permit types govern the channel: ฆท. for general and consumer-facing media, and ฆศ. for advertising directed at healthcare professionals. All amounts confirmed from Schedule 1 item 3.1 and Schedule 2 items 7.1 through 7.4 of the MoPH Notification B.E. 2568, which confirmed the same amounts as the superseded B.E. 2566 version.
| Permit Type | Admin Fee (THB) | Technical Assessment (THB) | Total (THB) | Validity |
|---|---|---|---|---|
| ฆศ. — advertising directed at healthcare professionals | 200 | 3,000 | 3,200 | Up to 5 years |
| ฆท. — advertising via general and consumer-facing media | 200 | 2,000 | 2,200 | Up to 5 years |
| Giveaway / promotional item — claims beyond name and logo | 200 | 200 | 400 | Up to 5 years |
| Giveaway / promotional item — name, company, and logo only | 200 | 200 | 400 | Up to 5 years |
GMP assessment fees depend on the location of the manufacturing site and the type of assessment required. Documentary verification is the standard route for overseas manufacturers in PIC/S-member countries. On-site inspection is the exception and is not routine for PIC/S-country manufacturers submitting a standard documentary verification.
| Assessment Type | Scenario | Fee (THB) |
|---|---|---|
| Documentary verification | GMP certificate from PIC/S-member authority; site in the same PIC/S country | 5,000 |
| Documentary verification | GMP certificate from PIC/S-member authority; site in a non-PIC/S country | 10,000 |
| Quality system document / paper assessment | All overseas manufacturers | 150,000 |
| On-site GMP inspection at overseas manufacturer | All overseas manufacturers; travel, accommodation, and per-diem expenses are borne by the applicant separately and not included in this figure | 200,000 |
| Certificate Basis | Initial Issue (THB) | Renewal (THB) |
|---|---|---|
| ASEAN Listed Inspection Service | 60,000 | 30,000 |
| PIC/S member authority | 60,000 | 30,000 |
| Certified by PIC/S-member authority or WHO Prequalification Team | 80,000 / 10,000 | 40,000 / 5,000 |
| Non-PIC/S member (all scenarios) | 150,000 | 150,000 |
| Inspection Type | Fee (THB) | Unit |
|---|---|---|
| Domestic GMP inspection (Thailand-based manufacturer) | 25,000 | Per inspection |
| GDP inspection — all facility types | 22,500 | Per inspection; flat rate effective B.E. 2568 (previously tiered 18,000 / 36,000 / 54,000) |
| GPP (Good Pharmacy Practice) inspection | 3,000 | Per inspection |
These fees apply to specific process types that arise during registration or post-approval. Not every product requires all of them. Under Clause 5 of the B.E. 2568 notification, where several applications share the same active ingredient and dosage form, use the same package insert, and are filed together, the second and each later application in that batch is charged Schedule 2 assessment at 25% of the first application's rate, a 75% reduction. The same structure applies to variation applications meeting those conditions. Note that bioequivalence study fees carry no equivalent reduction.
| Submission Type | Fee (THB) | Unit |
|---|---|---|
| BE study protocol (voluntary consultation) | 14,000 | Per protocol |
| BE study report | 34,000 | Per report |
| BCS-based biowaiver report | 22,000 | Per report |
| Dose proportionality-based biowaiver report | 14,000 | Per report |
| Domestic BE study site inspection | 50,000 | Per inspection; increased from 25,000 THB under B.E. 2568 |
| Domestic BE site readiness check for ASEAN BE MRA listing | 10,000 | Per inspection |
| Process | Fee (THB) | Notes |
|---|---|---|
| Safety Monitoring Program release (ปลด SMP) — technical assessment | 28,000 | Assessed when Thai FDA reviews accumulated post-marketing data to lift the SMP designation; application processing fee of 1,000 THB is additional |
| Clinical trial authorization — Type A (low risk) | 4,000 | Per authorization; risk type determined by Thai FDA |
| Clinical trial authorization — Type B (medium risk) | 4,000 | Per authorization |
| Clinical trial authorization — Type C (high risk) | 30,000 | Per authorization; the B.E. 2566 version had a single rate of 30,000 THB for all types |
| Amendment to clinical trial authorization | 2,000 | Per amendment application |