Thai FDA uses the ASEAN Common Technical Dossier (ACTD), not the ICH CTD format. A dossier assembled to ICH CTD standards will not pass Thai FDA screening regardless of the quality of the underlying science. Formatting compliance is not a formality: it is the gate between submission and review.
Thai FDA reviews dossiers in 2 stages. The first is screening: a format and completeness check conducted before the dossier enters substantive review. A dossier that fails screening is returned to the applicant without any technical assessment of its content. The applicant then resubmits, rejoins the queue, and loses the time already spent waiting.
The most common screening failure for international manufacturers is submitting documentation structured to ICH CTD standards. The ICH CTD and the ACTD are closely related in scientific content, but their organizational structure, section numbering, and language requirements differ in ways that Thai FDA enforces precisely. Familiarity with ICH CTD is not a substitute for knowledge of ACTD requirements.
A second common failure is incomplete Thai-language documentation in the sections where Thai FDA requires it. Part I of the ACTD, which covers administrative and product information, must include Thai-language labeling mock-ups and Thai-language product information. Submitting these sections in English only will fail screening.
The ASEAN Common Technical Dossier contains 4 parts. Unlike the ICH CTD's 5-module structure with a centralized summary module, the ACTD places quality, nonclinical, and clinical summaries at the beginning of their respective parts. There is no XML backbone; the ACTD uses a table of contents structure similar to the Non-eCTD Electronic Submission (NeeS) format.
Covers the application form, the drug product information document (equivalent to the summary of product characteristics), labeling mock-ups for inner and outer packaging, the patient information leaflet, and regional administrative documents including the establishment license of the local registration holder. Key sections of Part I must be submitted in Thai or in bilingual Thai-English format. Labeling errors and incomplete Thai translations are among the most common causes of screening rejection in Part I.
Covers the drug substance and drug product: manufacturing process, controls, specifications, container and closure system, and stability data. The quality summary and body of data are placed in Part II. For submissions where the manufacturing site has not previously been registered with Thai FDA, GMP accreditation documentation is submitted alongside Part II. Part II is accepted in English, though Thai FDA may issue queries in Thai requiring translated responses.
Covers pharmacology, pharmacokinetics, and toxicology data. The nonclinical summary and study reports are in Part III. For generic drug applications and new generic applications, Part III is generally not required: the nonclinical profile of the reference product is accepted in its place. For new drug applications, a full nonclinical Part III is required. Part III is submitted in English.
Covers clinical study reports, bioequivalence data, and clinical summaries. For new generics, Part IV contains the bioequivalence study or the approved waiver justification. For new drugs, a full clinical data package is required. For standard generics referencing an older comparator, Part IV requirements are abbreviated. Part IV is submitted in English.
Manufacturers with experience in ICH CTD submissions for EU, US, or Japanese markets will find the ACTD familiar in substance but different in architecture. The scientific data requirements are largely aligned; the structural and administrative differences are where submissions fail.
ICH CTD has 5 modules. Module 1 is region-specific administrative data; Modules 2-5 carry the scientific content. ACTD has 4 parts. Part I is administrative; Parts II-IV carry quality, nonclinical, and clinical data. The ACTD Parts II-IV broadly correspond to ICH CTD Modules 3-5, but section numbering and organization differ and cannot be directly mapped without reformatting.
In ICH CTD, quality, nonclinical, and clinical summaries are consolidated in Module 2. In ACTD, each summary appears at the start of its own Part. This means the ACTD document architecture cannot be rearranged from an ICH CTD submission: it must be assembled from the beginning to ACTD specifications.
ICH CTD electronic submissions use an XML backbone that defines the document hierarchy. ACTD uses a simple table-of-contents structure. Thai FDA's e-submission system accepts dossiers in the ACTD format; submitting an eCTD-formatted package to a system that expects ACTD will generate errors at the document validation stage.
ICH CTD submissions for EU or US markets are entirely in English (or the regional language). Thai FDA requires Thai-language content in Part I for labeling mock-ups, the product information document, and administrative sections. This requires accurate technical translation, not general translation: the approved Thai-language label becomes the legal standard for the product sold in Thailand.
Thai FDA's labeling requirements are detailed and enforced as part of the registration submission. The approved label is a legal document: any change after approval requires a variation submission. Getting the label right at the time of submission avoids a variation cycle before the product can be sold.
All drug products sold in Thailand must bear a label in Thai. The label must include the trade name, the approved indications, dosage instructions, contraindications, warnings, storage conditions, the name and address of the local registration holder (LAR), the manufacturing site, batch number format, expiry date format, and the Thai FDA registration number once approved. Bilingual labels (Thai and English) are permitted, but the Thai text must be complete and accurate.
Inner label, outer label, and patient information leaflet mock-ups must be included in Part I at the time of dossier submission. Thai FDA reviews these mock-ups as part of the assessment. Mock-ups that do not include all mandatory Thai-language elements will be cited in a screening query or returned. The approved mock-ups form the basis of the product's approved labeling.
Any change to the approved label after marketing authorization is granted requires a variation submission. Minor label changes, such as contact information updates for the LAR, are typically minor variations. Changes to indications, warnings, dosage instructions, or contraindications may be classified as major variations requiring prior approval before the revised label can be used commercially.
Thailand requires a patient information leaflet (PIL) in Thai for most prescription and non-prescription drugs. The PIL content must align exactly with the approved product information document. Discrepancies between the PIL and the approved document are a common query point during dossier review.
Foreign manufacturers sometimes treat screening as a minor administrative step before the real review begins. It is not. Screening is Thai FDA's quality gate, and it operates independently of the technical review queue. A dossier that fails screening is not reviewed; it is returned. The time spent waiting for screening is not credited toward the review clock when the dossier is resubmitted.
Screening checks include: correct ACTD format and section structure; completeness of all required sections for the registration category; presence of Thai-language documentation in Part I; valid establishment license of the LAR on record; and, for new manufacturers, GMP accreditation documentation for the manufacturing site.
A dossier that clears screening enters the substantive review queue. Thai FDA's official target from that point is 120 business days for a generic drug and 220 business days for a new drug, assuming no queries are issued. Queries during review reset the internal review clock. The most effective way to stay on the official timeline is to submit a dossier that raises no questions at screening and no queries during review: complete, correctly formatted, and technically clean on first submission.
We prepare ACTD dossiers in-house. Our team has assembled dossiers for generic, new generic, and new drug applications across multiple therapeutic categories. We know what Thai FDA's screening team checks, which sections generate queries, and what Thai-language labeling errors look like before they become a screening failure.
We do not reformat ICH CTD dossiers. We build ACTD submissions from source documents: the science goes in once, in the right structure, with the right Thai-language content, the first time. We do not add data to strengthen submissions when it is not required. We do not submit before a dossier is ready.
When clients bring us an existing dossier assembled for another market, we assess it against ACTD requirements and tell them exactly what needs to be reformatted, translated, or supplemented before it is ready for Thai FDA. That assessment takes days, not months, and it is the most efficient first step before any submission decision is made.