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, ICH 3.2.2

- 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
- 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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