What you actually need before a Thai FDA submission
The documents that get rejected most often are not the hardest ones — they are the incomplete ones. Here is the checklist our team runs before every submission.
Why applications get rejected
In our experience the top cause of rejection is not product quality — it is document completeness and internal consistency.
1. Incorrect product classification
First you must be able to answer which category your product falls into: drug, medical device, food, dietary supplement, cosmetic, or herbal product. Each has a completely different pathway, document set and timeline.
2. Technical documents not aligned to ACTD/ICH-CTD
The dossier must follow the prescribed module structure, each section must be internally consistent, and every claim needs supporting evidence.
3. Inconsistent data across documents
Product name, formulation, pack size and manufacturer details must match across every document in the set.
Pre-submission checklist
- Confirm product classification and regulatory pathway
- Verify technical dossier completeness by module
- Cross-check data consistency between documents
- Prepare country-of-origin certificates (CFS/CPP) and legalization
- Confirm importer/manufacturer facility licences are current
- Run a pre-submission simulation
If you are unsure whether your dossier is ready, we offer a pre-submission gap analysis.
- อย.
- Dossier
- ACTD