Thai-FDA eCTD

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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