Getting Ready for Adoption of eCTD 4.0

November 29, 2022
Getting Ready for Adoption of eCTD 4.0

Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates. The updates focus on addressing a few key constraints that both Agencies and sponsors have discovered over the last two (02) decades. The eCTD 4.0 aims at streamlining the review process of Regulatory information, which will continue to develop with each iteration of the eCTD, thereby highly benefitting the Regulatory submissions and publishing space.

Considerations for Adoption of eCTD 4.0

As we adapt to any system, it is essential to understand and consider the practical nuances, which need to be considered to ensure that the adoption of eCTD 4.0 goes smoothly for the applications at different stages with Health Authorities.

  • No stylesheet is available in eCTD 4.0 version which will make it difficult to view the submission TOC and content in the browser
  • Life-cycle management is challenging between eCTD v3.2.2 and v4.0
  • Requires cutting-edge technology and seasoned staff
  • When submitting the first eCTD v4.0 sequence to an eCTD v3.2.2 dossier, the next available sequence number is submitted as a whole number. For example, if the last eCTD v3.2.2 message has a sequence number “0003”, the first eCTD v4.0 submission unit will be sequence number “4”
  • When the submission is a continuation of an open Regulatory activity, the initial sequence number is needed to link the submission to the v3.2.2 Regulatory activity. The v3.2.2 sequence number should only be submitted to the first eCTD v4.0 submission for the open Regulatory activity
  • Once a v4.0 submission unit has been received for an application, all future sequences must be sent in v4.0 – i.e., a v3.2.2 message received after the initial v4.0 message, the latter will be rejected
  • All v3.2.2 applications included in an eCTD v4.0 grouped submission will be converted to v4.0 messages
  • When submitting v4.0 content that should be grouped with v3.2.2 content, the keyword codes and values must match

Timelines for Regions Adopting eCTD 4.0

The implementation guide for eCTD 4.0 was published by ICH in 2018 with minimal updates in June 2021. This will be adopted by Regulatory authorities throughout the world.

  • Japan finished its pilot in 2021 and will be the first to start implementing the new version in this year, 2022.
  • Brazil will commence with their pilot for the version 4.0 specification from 2023 onwards.
  • The pilot for Europe will also be for year 2023, post when the actual implementation dates will be decided. 
  • By end of 2023, Australia and the US will start with the implementations for the new version, with Switzerland beginning the following year. 
  • The pilot for Canada is planned for year 2023, and its implementation has been scheduled for the year 2024. 

Initially, the use of eCTD 4.0 will not be mandatory in all regions. An overlap period is anticipated when both eCTD 4.0 and 3.2.2 submissions will run in parallel, with each country defining its own grace period between two (02) - five (05) years before mandating the new version’s use. Find the table below for more details on the pilot and implementation dates for eCTD 4.0 region wise:  

Region​

Technical Pilot

Implementation Dates

ANVISA, Brazil​

2Q 2023 (Planned)​​

3Q 2023 (Production Pilot)​​
2023 (Voluntary)​​

EC, Europe​

2023 CAPs (Planned)​​

TBD​

FDA, United States​

2022​​

2023 (Voluntary)​​

2028 (Mandatory)​​

Health Canada, Canada​

2023 (Planned)​​

2024 (Voluntary)​​
2027 (Mandatory)​​

MHLW/PMDA, Japan​

2Q 2021 (Completed)​​

2022 (Voluntary)​​
2026 (Mandatory)​​

Swissmedic, Switzerland​

2023 (Planned)​​

2024 (Voluntary)​​
2028 (Mandatory)​​

TGA, Australia​

TBD​​

2023 (Voluntary)

 

In a nutshell, the primary goals of eCTD 4.0 are to implement changes that speed up the Regulatory submission process, enhance how Agencies and sponsors communicate, and improve global harmonization of the format.

With this thought, we at Freyr, being at the forefront of driving innovation through advanced tech-enabled products, will be geared towards supporting our customers by adopting eCTD 4.0 in our Regulatory submission and publishing software - Freyr SUBMIT PRO.

We recently conducted a webinar on eCTD 4.0, which also elaborates more about the change and Freyr’s readiness for eCTD 4.0. Please click here to download the archived webinar session.

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