Thai-FDA eCTD
Country: Thailand
Health Authority: Thailand Food and Drug Administration (Thai FDA)
eCTD, Accepted Since: Pilot eCTD from October 2014 and HA scheduled to receive eCTD from May, 2015
eCTD Version: Module 1 Specification v1.0, M2-M5 – v3.2.2 and M1-M5 – v4.0
- A: Pharmaceutics - New Chemical Entity
- A: Pharmaceutics - New Salt or Ester of Existing Active Ingredient
- A: Pharmaceutics - New Dosage Form
- A: Pharmaceutics - New Route of Administration
- A: Pharmaceutics - New Combination
- A: Pharmaceutics – Abridge application
- A: Pharmaceutics - New Medicinal Product (Others)
- A: Pharmaceutics - New Generic
- A: Pharmaceutics - Generic
- A: House Hold Remedies
- B: Biologics - Vaccine
- B: Biologics - Blood and Plasma Derived Product
- B: Biologics - Cell and Tissue- Based Therapy Product
- B: Biologics - Biotechnology Product
- B: Biologics - Biosimilar Product
- B: Biologics - Abridge application
- B: Biologics - Others
- C: Veterinary - New Medicinal Product
- C: Veterinary - New Generic Medicinal Product
- C: Veterinary - Generic Medicinal Product
- C: Veterinary - Medicated Premixed
- C: Veterinary - Biologics
- D: Traditional Medicinal Product
- F: Variation - Major Variation (MaV)
- F: Variation - Minor Variation (MiV-PA)
- F: Variation - Minor Variation (MiV-N)
- F: Variation - Others
- G: Clinical Trial Authorization Application
- G: Clinical Trial Authorization Amendments
- H: Review of SMP Application
- H: Risk Management Plan
- H: Pharmacovigilance
- H: Periodic Safety Update Report
- I: Drug Master Files
- I: Plasma Master Files
- I: Vaccine Antigen Master File
- I: Tissue Master File
- J: Supplementary Information
- K: Orphan Drug Application
- K: Emergency Used Application
- L: Consultative Application
- Z: Undefined Regulatory Activity
Process to be followed to make a Thai FDA submission
- Obtain the eSubmission identifier from Thai FDA online service
- Learn about the Thai M1 Specification for eCTD requirements
- Review the eCTD submission guidance
- Submit the application form and compliant PDFs
- Submit the eCTD submission via electronic media
How can Freyr help?
- Guarantee your ROI with an eCTD software that optimizes cost-per-submission
- Integration with inbuilt eCTD validator and PDF manager, submissions tracker and HA query management tool
- eCTD software solutions and services from the secure certified cloud, pay-per-use model on usage volume with minimal investment.
For more information on the same, consult us
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