When can companies expect to use eCTD 4.0?

Let us find out together about the latest status of eCTD 4.0 around the world

 The eCTD standard has been evolving for over two decades, and we have seen the transition of many global regulators implementing the eCTD v3.2 standard. As many have utilized eCTD, it is only natural that we see the best practices moving into the next version: eCTD v4.0.

In 2010, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) founded M8 EWG. This EWG (Expert Working Group) was founded to take over developing and revising the eCTD 4.0 Implementation Guide and related documents. 2015, the ICH published Step 4 – the ICH eCTD v4.0 Implementation Package v1.0 and related files. This package has since been updated in 2018 with the latest version, 1.3.

In the latest version, ICH’s Step 5 for regional implementation, several health authorities are working on implementation guidelines for eCTD v4.0 to include their regional parts. In eCTD v4.0, there will be no distinction between the regional part and the (ICH) part, and there will be only one backbone for all modules. Other advantages are the possibility to reuse documents that have already been submitted to authorities and improved lifecycle management of documents. Let’s look at the current regulatory status on eCTD 4.0 implementation dates for each authority.

FDA – United States of America

Module 1 eCTD 4.0 Implementation Guide – published.
Voluntary date of eCTD v4.0 use – 2023
Mandatory date of eCTD v4.0 use – 2028

EMA – European Union

Module 1 eCTD 4.0 Implementation Guide – published.
Voluntary date of eCTD v4.0 use – 2024 (Voluntary CAPs)
Mandatory date of eCTD v4.0 use – 2026 (Mandatory CAPs)

SwissMedic – Switzerland

Module 1 eCTD 4.0 Implementation Guide – drafted.
Voluntary date of eCTD v4.0 use –2024
Mandatory date of eCTD v4.0 use – 2028

ANVISA – Brazil

Module 1 eCTD 4.0 Implementation Guide – unreleased – expected Q1/2023.
Voluntary date of eCTD v4.0 use – Q3/2023
Mandatory date of eCTD v4.0 use – unknown

PMDA – Japan

Module 1 eCTD 4.0 Implementation Guide – drafted.
Voluntary date of eCTD v4.0 use – 2022
Mandatory date of eCTD v4.0 use – 2026

TGA – Australia

Module 1 eCTD 4.0 Implementation Guide – publish date set to April 2021.
Voluntary date of eCTD v4.0 use – 2023
Mandatory date of eCTD v4.0 use – unknown

Health Canada – Canada

Module 1 eCTD 4.0 Implementation Guide – publish date set to December 2021.
Voluntary date of eCTD v4.0 use – 2023
Mandatory date of eCTD v4.0 use – 2026

For more details, please also look at the official ICH website for eCTD 4.0.

If you have any other questions or need more information about eCTD 4.0, please get in touch with us at info@extedo.com or have a look at our Blog Post “What is eCTD 4.0 ”.