Differences Between eCTD and ACTD Dossier

by

eCTD (Electronic Common Technical Document)

  • Definition: The electronic Common Technical Document (eCTD) is a harmonized regulatory submission format developed by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH). It is used by regulatory authorities in many parts of the world.
  • A globally harmonized format developed by ICH.
  • Accepted in regions like the US, EU, Japan, and Canada.
  • Structure:
    • Module 1: Admin Info
    • Module 2: Summary of Modules 3-5
    • Module 3: Quality
    • Module 4: Nonclinical Data
    • Module 5: Clinical Data
  • Submission: Electronic, widely used for international submissions.


ACTD (ASEAN Common Technical Dossier)

  • Definition: The ASEAN Common Technical Dossier (ACTD) is a harmonized submission format developed for ASEAN (Association of Southeast Asian Nations) countries. It is designed to facilitate the registration process across Southeast Asian countries.
  • Developed for Southeast Asian markets under ASEAN.
  • Used in the 10 ASEAN countries, namely Brunei Darussalam, Cambodia, Indonesia, Laos, Malaysia, Myanmar, Philippines, Singapore, Thailand, and Vietnam.
  • Structure:
    • Part I: Admin Data
    • Part II: Quality & Summary
    • Part III: Nonclinical Data & Summary
    • Part IV: Clinical Data & Summary
  • Submission: Paper or electronic, specific to ASEAN requirements.

Key Differences

  • Region: ICH countries vs. ASEAN
  • Format: 5 Modules (eCTD) vs. 4 Parts (ACTD)
  • Language: Mostly English (ICH) vs. Local languages or English (ASEAN)
  • Submission: Fully electronic (eCTD) vs. both paper/electronic (ACTD)


Read also:


Resource Person: KABYA PRATAP ROYAL

Leave a Comment