10 Small Submissions
No more than 10 Documents per submission
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.
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.
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.
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) |
EC, Europe |
2023 CAPs (Planned) |
TBD |
FDA, United States |
2022 |
2023 (Voluntary) 2028 (Mandatory) |
Health Canada, Canada |
2023 (Planned) |
2024 (Voluntary) |
MHLW/PMDA, Japan |
2Q 2021 (Completed) |
2022 (Voluntary) |
Swissmedic, Switzerland |
2023 (Planned) |
2024 (Voluntary) |
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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