What is eCTD 4.0?

The Evolution and Advantages of eCTD 4.0 in Global Regulatory Submissions

Mon Dec 4, 2023


The Electronic Common Technical Document (eCTD) has become the standard format for submitting regulatory information to drug regulatory agencies globally. The release of eCTD 4.0 in 2022 marked a significant leap forward, introducing transformative features and enhancements for pharmaceutical, biologics, and medical device companies.

Key Features of eCTD 4.0:

  1. Forward Compatibility:
    • eCTD 4.0 submissions are compatible with both eCTD 4.0 and the older version, eCTD 3.2.2.
    • This ensures sponsors can submit applications in the latest format without concerns about compatibility with regulatory agencies.
  2. Controlled Vocabularies:
    • eCTD 4.0 incorporates controlled vocabularies, ensuring the use of approved terms to describe different aspects of a drug product.
    • This promotes consistency and accuracy in regulatory submissions.
  3. Additional Improvements:
    • Enhanced Metadata: Detailed and informative metadata facilitates better understanding and processing by regulatory agencies.
    • Improved Usability: User interface enhancements make it simpler for sponsors to create and submit eCTD applications.
    • Technology Support: eCTD 4.0 accommodates new technologies like cloud computing and mobile devices, providing flexibility for global submissions.

Benefits of eCTD 4.0:

  1. Efficiency:
  2. Streamlines the regulatory submission process, saving sponsors time and resources.

  3. Accuracy:
  4. Controlled vocabularies ensure consistency, contributing to more accurate regulatory submissions.

  5. Security:
  6. eCTD 4.0 boasts enhanced security measures, reducing susceptibility to fraud and data breaches.

  7. Technology Integration:
  8. Supports cloud computing and mobile devices, enabling sponsors to submit applications from anywhere in the world.

  9. Improved Communication:
  10. Facilitates a more collaborative review process between sponsors and regulatory authorities.

  11. Enhanced Compliance:
  12. Ensures submissions align with regulatory requirements through a robust validation and translation process.

    Global Implementation Status:

    • The US FDA and Japan PMDA are voluntarily accepting eCTD 4.0 submissions.
    • Other countries are in the process of implementing eCTD 4.0, with specific deadlines yet to be established.


    • The adoption of eCTD 4.0 represents a global initiative to enhance the efficiency and effectiveness of the regulatory review process for medicinal products.
    • As more countries embrace eCTD, it is poised to become the universal standard for regulatory submissions worldwide.
    • The overarching goals of eCTD 4.0 include expediting the regulatory submission process, fostering improved communication between agencies and sponsors, and promoting global harmonization in format standards.

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