One CTD. Two regulatory authorities.
The Thai FDA reads in Thai. The sponsor reads in English. Module 3 (CMC) must be identical. Module 5 (Clinical) must be identical. Patient consent in Thai matches the protocol in English. SAEs cross the language line every day. Othello translates the pharmaceutical and medical device document chain — CTD modules 1-5, protocols, Investigator’s Brochure, patient-facing ICF, SAE narratives, DSUR/PSUR, SmPC/PIL, IFU, GMP audits — with consistent terminology aligned to Drug Act B.E. 2510, Medical Device Act B.E. 2551, ICH-GCP, PIC/S GMP, and the ASEAN ACTD / AMDD frameworks.
(1967, amended)
(2008, amend 2019)
E6(R3) current
GMP harmonised
The Thai FDA translated ICH-GCP in 2000.
The Thai pharmaceutical regulatory framework is fundamentally bilingual. The Thai FDA translated ICH-GCP into Thai in 2000 — establishing the bilingual record as the standard for clinical research conducted in Thailand. Every clinical trial, every CTD submission, every adverse event report crosses the same language line.
Clinical trials in Thailand should follow international codes of ethics such as the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use and Good Clinical Practice (ICH/GCP). In 2000 the FDA translated the ICH/GCP into Thai for ease of reference and to act as guidelines.
The 2000 Thai translation of ICH-GCP was not symbolic — it made the international standard operationally enforceable in Thai-language clinical research. Every Thai investigator, every Thai Ethics Committee, every Thai Clinical Trials Registry submission can reference the Thai-translated ICH-GCP. But sponsors and CROs still work in English-language ICH-GCP. The two documents must say the same thing. When an investigator at Bumrungrad enrols a Thai patient under a protocol drafted in English, the patient signs an ICF in Thai. When the patient experiences an SAE, the report flows to both Thai FDA in Thai and the sponsor’s global safety database in English. The bilingual record is not optional — it is the foundation of Thai clinical research.
Drug Act. MD Act. ICH-GCP.
Thailand’s life sciences regulation rests on three pillars. The Drug Act B.E. 2510 governs pharmaceuticals. The Medical Device Act B.E. 2551 (substantially amended 2019, in force 2021) governs devices. ICH-GCP governs clinical trials. Three distinct frameworks, all administered by the Thai FDA under the Ministry of Public Health.
เภสัชกรรม regulation
Primary legislation for pharmaceutical products. Medicines Regulation Division (MRD) of Thai FDA oversees registration, importation, manufacturing, and marketing authorization.
- Drug Act B.E. 2510 (1967) + amendments
- Thai FDA Medicines Regulation Division
- ASEAN ACTD / ICH CTD dossier format
- PIC/S GMP compliance mandatory
- Thai language labelling required
- Bridging studies may be required
- Manufacturer + product registration
- ATMPs (cell, gene, tissue) regulated here
เครื่องมือแพทย์ regulation
Major reform in force from 15 February 2021. Medical Device Control Division (MDCD) of Thai FDA. Aligned with ASEAN Medical Device Directive (AMDD) 4-class risk system.
- Medical Device Act B.E. 2551 (2008)
- Amended B.E. 2562 (2019) in force 2021
- ASEAN AMDD 4-class risk (Class 1-4)
- CSDT format mandatory (Class 2-4)
- SKYNET e-submission portal
- ISO 13485 quality required
- 5-year license validity
- Concise Evaluations (April 2024)
Clinical Trials framework
Mandatory for trials in Thailand. Thai FDA translated ICH-GCP into Thai in 2000. Backed by Ethics Committee approval (FERCIT) and Clinical Trial Authorization (CTA).
- ICH-GCP E6(R3) current
- Thai Clinical Trials Registry required
- Ethics Committee approval (FERCIT)
- Clinical Trial Authorization (CTA)
- Investigational drug import licence (4 yr)
- Helsinki Declaration ethics
- Informed Consent Form in Thai
- Bridging study if no Thai patients
Ministry. Authority. Division.
The Thai life sciences regulatory hierarchy. The Ministry of Public Health (MoPH) houses the Thai FDA. The Thai FDA houses the Medicines Regulation Division (MRD) and the Medical Device Control Division (MDCD). Each has its own document format, submission channel, and review timeline.
Three levels. One bilingual dossier.
The Ministry of Public Health (MoPH) is the cabinet-level authority. The Thai FDA — Food and Drug Administration — operates as the principal regulator within MoPH. Within Thai FDA, separate divisions handle pharmaceuticals and devices. The Medicines Regulation Division handles drugs (Drug Act B.E. 2510). The Medical Device Control Division handles devices (MD Act B.E. 2551 amended 2562). Both report up to Thai FDA leadership.
ICH. PIC/S. ASEAN. ISO. CIOMS.
Thai life sciences regulation operates inside a stack of international harmonisation frameworks. ICH for clinical and quality. PIC/S for manufacturing inspection. ASEAN ACTD/AMDD for regional harmonisation. ISO for quality management. CIOMS for safety reporting. Each framework has its own controlled vocabulary.
Good Clinical Practice
International ethical and scientific quality standard for clinical trials. Mandatory in Thailand. Thai FDA translated in 2000.
การผลิต inspection
Pharmaceutical Inspection Co-operation Scheme. Thailand member since 2016. GMP Guide operationally adopted.
Common Technical เอกสาร
Regional dossier format. Aligned with ICH CTD. Standard submission format across ASEAN markets.
เครื่องมือแพทย์ Directive
Regional device framework. 4-class risk classification. CSDT submission format. Thailand aligned 2021.
เครื่องมือแพทย์ QMS
Quality management system for medical device manufacturers. Required for Thai FDA device registration.
Device clinical investigation
Good clinical practice for medical device clinical investigations. Equivalent of ICH-GCP for devices.
Safety reporting
Council for International Organizations of Medical Sciences. Standard form for SAE/SUSAR reporting.
Research ethics
Declaration of Helsinki — World Medical Association ethical principles for medical research involving human subjects.
Five modules. Two languages. Zero divergence.
The Common Technical Document (CTD) is the standardised five-module dossier format used to submit pharmaceutical applications worldwide. Thailand uses ASEAN ACTD, closely aligned with ICH CTD. Module 1 is regional (Thai); Modules 2-5 are shared across jurisdictions. The bilingual bridge spans the entire dossier.
Module 1 in Thai. Modules 2-5 must match.
The Thai FDA reviews Module 1 in Thai — the regional application form, the SmPC (Summary of Product Characteristics), the PIL (Patient Information Leaflet), the cover letter, the proposed Thai labelling. The sponsor’s global regulatory affairs team manages Modules 2-5 in English — these are reused across many jurisdictions and must remain consistent. When the SmPC in Module 1 (Thai) describes the indication or contraindication differently from the Clinical Overview in Module 2 (English), the Thai FDA reviewer raises a query — and the approval timeline extends.
Regional (Thai)
- Cover letter
- Application forms
- SmPC (Thai)
- PIL (Thai)
- Labelling (Thai)
- Expert reports
CTD Summaries
- Quality Overall Summary
- Non-Clinical Overview
- Clinical Overview
- Tabulated summaries
คุณภาพ CMC
- Drug substance
- Drug product
- การผลิต
- Stability data
- Specifications
Non-Clinical reports
- Pharmacology
- Pharmacokinetics
- Toxicology
- Animal studies
Clinical reports
- Biopharmaceutic studies
- Clinical Study Reports (CSRs)
- Adverse event narratives
- Statistical analyses
Oncology. Vaccines. ATMPs.
All major therapeutic areas with sector-specific termbases. Oncology and vaccines are the largest engagement volumes. ATMPs (cell, gene, tissue therapy) under the Drug Act B.E. 2510 are the highest-margin work. Medical devices and IVDs are growing fast under the 2021 AMDD alignment.
Cancer therapeutics
Chemotherapy · immunotherapy · targeted therapy · CAR-T cell therapy · radiopharmaceuticals · oncology biosimilars.
Vaccine programmes
Paediatric · adult · travel medicine · pandemic preparedness. Bilingual ICF and protocol amendments at scale.
Cell & gene therapy
Cell therapy · gene therapy · tissue-engineered · combined ATMPs. Under Drug Act B.E. 2510, MRD oversight.
Heart & vascular
Anticoagulants · antihypertensives · statins · cardiac devices · stents · pacemakers · cardiac surgery.
Metabolic care
Insulin · GLP-1 agonists · SGLT2 inhibitors · continuous glucose monitors · thyroid · osteoporosis.
HIV · TB · antibiotics
HIV antiretrovirals · tuberculosis treatments (Thailand significant TB burden) · antimicrobials · hepatitis.
Class 1-4 devices
Imaging · implants · surgical instruments · IVDs · point-of-care · software as a medical device (SaMD).
CNS & neurology
Antidepressants · antipsychotics · neurology · pain management · anaesthetics · sleep medicine.
From CTD to ICF to SAE.
A typical pharmaceutical or medical device engagement generates a substantial document family spanning regulatory submissions, product information, clinical trial documentation, pharmacovigilance, and quality. Each document family has its own controlled vocabulary, regulatory framework, and reporting timeline.
Thai-English. Global sponsor pairs.
Thai-English is the primary pair for Thai FDA submissions and clinical trials with international sponsors. Thai-Japanese for Takeda, Astellas, Eisai, Otsuka. Thai-Chinese for biosimilar manufacturers. Thai-Korean for emerging biotech. CLMV pairs for regional clinical trial sites and ASEAN harmonised registrations.
Sponsors, CROs, MNCs already on the roster.
Global pharma sponsors running Thai clinical trial sites. CROs managing multi-site studies. Medical device MNCs filing under the amended MD Act. PDPA-compliant clinical trial data handling. MedDRA-aligned SAE terminology. NDA from first email.
2M+ words/month. ICH-GCP precision.
ISO 17100:2015 · ATA · ATC accredited · GDPR + PDPA compliant · Drug Act B.E. 2510 · MD Act B.E. 2551 (amended 2562) · ICH-GCP E6(R3) · PIC/S GMP · ASEAN ACTD · ASEAN AMDD · CSDT · ISO 13485 · ISO 14155 · CIOMS · MedDRA terminology · PDPA-compliant clinical data handling · Bangkok
MedDRA. CIOMS. Thai. English.
Same methodology as the rest of the practice — but with the highest precision standards in the firm. MedDRA-aligned terminology for adverse events. CIOMS form templates for safety reporting. ICH-GCP controlled vocabulary. Therapeutic-area termbases from prior work.
The adverse event term. Identical in both languages.
Life sciences translation has the lowest tolerance for terminological variance in the firm. An SAE filed as “ventricular fibrillation” in English but appearing as a different cardiac event in Thai is a regulatory non-compliance finding. The MedDRA dictionary (Medical Dictionary for Regulatory Activities) provides the controlled vocabulary used globally for adverse event coding — and Othello maintains MedDRA-aligned Thai-English mappings for every therapeutic area covered.
For CTD submissions, the controlled vocabulary spans Module 1 (Thai regional content), Module 2 (overviews and summaries), Module 3 (CMC manufacturing terms), Module 4 (non-clinical pharmacology), and Module 5 (clinical study reports). Every translation engagement starts with a glossary lock — sponsor confirms the controlled vocabulary, Othello applies it consistently across the document family. For sustained engagements (ongoing pharmacovigilance, multi-year trial programmes, multi-product portfolios), the termbase grows project-by-project and becomes a client-specific asset.
MRD reviews. PIC/S GMP. ICH-GCP.
- Drug Act B.E. 2510 (1967) + amendments
- Medicines Regulation Division (MRD)
- ASEAN ACTD / ICH CTD format
- PIC/S GMP compliance (member 2016)
- ICH-GCP for clinical trials
- Bridging studies may be required
- Thai language labelling mandatory
- ATMPs (cell, gene, tissue) regulated here
MDCD reviews. 4-class. CSDT. ISO 13485.
- MD Act B.E. 2551 (amended 2562, in force 2021)
- Medical Device Control Division (MDCD)
- ASEAN AMDD 4-class risk system
- CSDT submission format (Class 2-4)
- SKYNET e-submission portal
- ISO 13485 quality management
- 5-year license validity
- Concise Evaluations from April 2024
Life sciences grid. Verified facts.
Statutory, framework, and market reference numbers for the Thai life sciences regulatory landscape and the international harmonisation frameworks that anchor the bilingual record.
(1967, amended)
in force (B.E. 2562)
GMP harmonised
per ASEAN AMDD
Questions worth answering.
What is the Thai regulatory framework for pharmaceuticals?
What is the Thai regulatory framework for medical devices?
What is the CTD and why does it need bilingual translation?
What is ICH-GCP and is it mandatory in Thailand?
What is PIC/S and what does Thailand’s membership mean?
What documents need translation for a clinical trial?
How are SAEs handled in bilingual pharmacovigilance?
What therapeutic areas does Othello cover?
How is clinical trial data handled under PDPA?
Send the protocol. We’ll hold the dossier.
Send the CTD scope, the device class, the therapeutic area, the lender or regulator framework. Othello translates the document family — CTD modules 1-5, protocols, Investigator’s Brochure, patient-facing ICF, SAE narratives, DSUR/PSUR, SmPC/PIL, IFU, GMP audits — with MedDRA-aligned terminology and CIOMS-format safety reports. ISO 17100 · ATA · ATC · GDPR · PDPA.
