eCTD Filing Types for TH
Calyx RIM provides the following filing types for all application types associated with Thailand (TH). This table lists the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Types |
|---|---|---|---|
| A: Pharmaceutics - New Chemical Entity | th-0-92 | a-ph-newce | CTA, NDA |
| A: Pharmaceutics - New Salt or Ester of Existing Active Ingredient | th-0-92 | a-ph-newse | CTA, NDA |
| A: Pharmaceutics - New Dosage Form | th-0-92 | a-ph-newdosage | CTA, NDA |
| A: Pharmaceutics - New Route of Administration | th-0-92 | a-ph-newroute | CTA, NDA |
| A: Pharmaceutics - New Combination | th-0-92 | a-ph-newcomb | CTA, NDA |
| A: Pharmaceutics - New Medicinal Product (Others) | th-0-92 | a-ph-newothers | CTA, NDA |
| A: Pharmaceutics - New Generic | th-0-92 | a-ph-newgen | CTA, NDA |
| A: Pharmaceutics - Generic | th-0-92 | a-ph-generic | CTA, NDA |
| A: House Hold Remedies | th-0-92 | a-ph-house | CTA, NDA |
| B: Biologics - Vaccine | th-0-92 | b-bio-vaccine | CTA, NDA |
| B: Biologics - Blood and Plasma Derived Product | th-0-92 | b-bio-blood | CTA, NDA |
| B: Biologics - Cell- and Tissue- Based Therapy Product | th-0-92 | b-bio-cell | CTA, NDA |
| B: Biologics - Biotechnology Product | th-0-92 | b-bio-biotech | CTA, NDA |
| B: Biologics - Biosimilar Product | th-0-92 | b-bio-biosimilar | CTA, NDA |
| B: Biologics - Others | th-0-92 | b-bio-others | CTA, NDA |
| C: Veterinary - New Medicinal Product | th-0-92 | c-vet-newprod | CTA, NDA |
| C: Veterinary - New Generic Medicinal Product | th-0-92 | c-vet-newgeneric | CTA, NDA |
| C: Veterinary - Generic Medicinal Product | th-0-92 | c-vet-generic | CTA, NDA |
| C: Veterinary - Medicated Premixed | th-0-92 | c-vet-premixed | CTA, NDA |
| C: Veterinary - Biologics | th-0-92 | c-vet-bio | CTA, NDA |
| D: Traditional Medicinal Product | th-0-92 | d-traditional | CTA, NDA |
| F: Variation - Major Variation (MaV) | th-0-92 | f-var-major | CTA, NDA |
| F: Variation - Minor Variation (MiV-PA) | th-0-92 | f-var-minor-pa | CTA, NDA |
| F: Variation - Minor Variation (MiV-N) | th-0-92 | f-var-minor-n | CTA, NDA |
| F: Variation - Others | th-0-92 | f-var-others | CTA, NDA |
| G: Clinical Trial Authorization Application | th-0-92 | g-clin-authapp | CTA, NDA |
| G: Clinical Trial Authorization Amendments | th-0-92 | g-clin-authamend | CTA, NDA |
| H: Review of SMP Application | th-0-92 | h-review-smph | CTA, NDA |
| H: Risk Management Plan | th-0-92 | h-riskmgtplan | CTA, NDA |
| H: Pharmacovigilance | th-0-92 | h-pv | CTA, NDA |
| H: Periodic Safety Update Report | th-0-92 | h-psur | CTA, NDA |
| I: Drug Master Files | th-0-92 | i-dmf | CTA, NDA |
| I: Plasma Master Files | th-0-92 | i-pmf | CTA, NDA |
| I: Vaccine Antigen Master File | th-0-92 | i-vamf | CTA, NDA |
| I: Tissue Master File | th-0-92 | i-tmf | CTA, NDA |
| J: Supplementary Information | th-0-92 | j-suppl | CTA, NDA |
| K: Orphan Drug Application | th-0-92 | k-orphan | CTA, NDA |
| K: Emergency Used Application | th-0-92 | k-emergency | CTA, NDA |
| Z: Undefined Regulatory Activity | th-0-92 | z-undefined-regact | CTA, NDA |
| A: Pharmaceutics - New Chemical Entity | th-1-0 | a-ph-newce | CTA, NDA |
| A: Pharmaceutics - New Salt or Ester of Existing Active Ingredient | th-1-0 | a-ph-newse | CTA, NDA |
| A: Pharmaceutics - New Dosage Form | th-1-0 | a-ph-newdosage | CTA, NDA |
| A: Pharmaceutics - New Route of Administration | th-1-0 | a-ph-newroute | CTA, NDA |
| A: Pharmaceutics - New Combination | th-1-0 | a-ph-newcomb | CTA, NDA |
| A: Pharmaceutics – Abridge application | th-1-0 | a-ph-abridge | CTA, NDA |
| A: Pharmaceutics - New Medicinal Product (Others) | th-1-0 | a-ph-newothers | CTA, NDA |
| A: Pharmaceutics - New Generic | th-1-0 | a-ph-newgen | CTA, NDA |
| A: Pharmaceutics - Generic | th-1-0 | a-ph-generic | CTA, NDA |
| A: House Hold Remedies | th-1-0 | a-ph-house | CTA, NDA |
| B: Biologics - Vaccine | th-1-0 | b-bio-vaccine | CTA, NDA |
| B: Biologics - Blood and Plasma Derived Product | th-1-0 | b-bio-blood | CTA,NDA |
| B: Biologics - Cell- and Tissue- Based Therapy Product | th-1-0 | b-bio-cell | CTA, NDA |
| B: Biologics - Biotechnology Product | th-1-0 | b-bio-biotech | CTA, NDA |
| B: Biologics - Biosimilar Product | th-1-0 | b-bio-biosimilar | CTA, NDA |
| B: Biologics – Abridge application | th-1-0 | b-bio-abridge | CTA, NDA |
| B: Biologics - Others | th-1-0 | b-bio-others | CTA, NDA |
| C: Veterinary - New Medicinal Product | th-1-0 | c-vet-newprod | CTA, NDA |
| C: Veterinary - New Generic Medicinal Product | th-1-0 | c-vet-newgeneric | CTA, NDA |
| C: Veterinary - Generic Medicinal Product | th-1-0 | c-vet-generic | CTA, NDA |
| C: Veterinary - Medicated Premixed | th-1-0 | c-vet-premixed | CTA, NDA |
| C: Veterinary - Biologics | th-1-0 | c-vet-bio | CTA, NDA |
| D: Traditional Medicinal Product | th-1-0 | d-traditional | CTA, NDA |
| F: Variation - Major Variation (MaV) | th-1-0 | f-var-major | CTA, NDA |
| F: Variation - Minor Variation (MiV-PA) | th-1-0 | f-var-minor-pa | CTA, NDA |
| F: Variation - Minor Variation (MiV-N) | th-1-0 | f-var-minor-n | CTA, NDA |
| F: Variation - Others | th-1-0 | f-var-others | CTA, NDA |
| G: Clinical Trial Authorization Application | th-1-0 | g-clin-authapp | CTA, NDA |
| G: Clinical Trial Authorization Amendments | th-1-0 | g-clin-authamend | CTA, NDA |
| H: Review of SMP Application | th-1-0 | h-review-smph | CTA, NDA |
| H: Risk Management Plan | th-1-0 | h-riskmgtplan | CTA, NDA |
| H: Pharmacovigilance | th-1-0 | h-pv | CTA, NDA |
| H: Periodic Safety Update Report | th-1-0 | h-psur | CTA, NDA |
| I: Drug Master Files | th-1-0 | i-dmf | CTA, NDA |
| I: Plasma Master Files | th-1-0 | i-pmf | CTA, NDA |
| I: Vaccine Antigen Master File | th-1-0 | i-vamf | CTA, NDA |
| I: Tissue Master File | th-1-0 | i-tmf | CTA, NDA |
| J: Supplementary Information | th-1-0 | j-suppl | CTA, NDA |
| K: Orphan Drug Application | th-1-0 | k-orphan | CTA, NDA |
| K: Emergency Used Application | th-1-0 | k-emergency | CTA, NDA |
| L: Consultative Application | th-1-0 | l-consult | CTA, NDA |
| Z: Undefined Regulatory Activity | th-1-0 | z-undefined-regact | CTA, NDA |