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Are you ready for eCTD 4.0?

Key business drivers for the next major version of eCTD

The goal of upgrading to eCTD 4.0 is to modernize and improve efficiencies with submission approvals, to accommodate for more complexity to support a wider variety of product types, and to streamline to simplify submission management. While compliance with the health agencies' eCTD 4.0 implementation timelines (e.g., Japan and US FDA) is still the main motivator for many sponsors, there are other business benefits to consider such as:

Improved Communication
  • Updated lifecycle operations
  • Potential for two-way communications
Increased flexibility
  • Ability to correct or harmonize metadata (e.g., display name, manufacturer, substance) across applications and sequences
  • Ability to change document granularity while maintaining life cycle relationships
  • Reuse documents submitted previously
  • Context of use and keywords (e.g., manufacturer's name) used to group similar information

Are you prepared for eCTD 4.0?

Do you know your document authoring process needs to be reassessed to become eCTD 4.0 ready?

While there are no major changes expected to the application/sequence population and publishing process, there are going to be minor changes that could impact your document authoring business practices. Changes in how metadata is input and how documents can be lifecycled will be important to understand. Also, as health authorities interpret their own requirements, this could bring changes to existing reports and internal definitions or terminology.

Do you understand how your controlled vocabulary components need to be revisited?

Controlled vocabularies and management of them will become even more important with eCTD 4.0. This could require you to map the data that is currently in your applications and to seek to understand what data is already on file with the agencies that was provided in the form of Structured Labeling and Application forms. Ensuring CV management capabilities are available with your selected toolset will be important.

Are you aware of the timelines set by agencies so that you can make timely business decisions and implement changes?

While it seems like the topic of eCTD 4.0 has been around for a long time with slow movement, we are seeing many regulators announcing pilots and revised implementation plans. We've even seen regulators who have not yet implemented eCTD debate moving directly to 4.0. Below are some key regions to keep an eye on:

  • Japan: Currently optional, but will become mandatory in 2026.
  • United States: US FDA completed their pilot in 2023. Both CDER and CBER plan to start accepting new drug applications (NDA/BLA) in 2024, eventually making eCTD 4.0 format mandatory by 2029.
  • Australia: Specification expected soon, pilot considered end of 2024.
  • Switzerland: Finalized specification expected in early 2024.
  • Europe: More action expected in 2024 ‐
    2024: Technical Pilot CAPs
    2025: Voluntary for CAPs
    2026: Voluntary for MRP/DCP/NAP
    2027: Mandatory for CAPs
  • Other regions: Still in consideration. You can visit for more information.

LORENZ has been closely engaged with industry and agency customers to support conceptual and technical activities for the implementation of eCTD 4.0. LORENZ docuBridge was utilized to support the US FDA's eCTD 4.0 successful pilot that ended in 2023. LORENZ engaged with 20 customers to test eCTD 4.0 functionality in docuBridge, some of which were involved in the US FDA pilot.

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