- EMA announced new timelines for eCTD 4.0 implementation on 8 July. The mandatory date for new CAP MAA submissions is now 2028. Existing CAPs are still to be confirmed.
- FDA released a new eCTD 4.0 CV Package on 9 July. Changes are limited to a new OID for the overall package in line with the previous update to the specification in November.
You might have noticed that we’ve sent fewer alerts recently as there have been fewer updates from the regulatory agencies. We’re switching to a monthly cadence for now – if the agencies pick up the pace, so will we!
EMA – eCTD 4.0
Summary of Change:
New timelines have been announced for new CAP submissions in eCTD 4.0:
• Strongly Recommended – Q1 2027
• Mandatory – Q1 2028
Existing CAPs as well as MRP/DCP/National submissions are still to be confirmed.
Effective Date:
Q1 2028
Effective Date:
TBC
Version:
FDA – eCTD 4.0
Summary of Change:
Update to overall eCTD 4.0 CV OID in line with the specification update in November. Specification version 1.8.
Effective Date:
9 July 2026
Effective Date:
2029
Version:
Process for Inclusion of HA Requirements in Ennov InSight
As a reminder, we follow the below process for tracking, managing and implementing regulatory requirements.
- The Regulatory Consulting team monitors websites for any emerging or updated specifications
- The RC team collaborates with Product Owner team to identify product impacts and craft high-level requirements
- Once the requirements and product impacts are understood an estimate for the change(s) is created and development work is prioritized based on the estimate
- A target release date is set by Product Management which is communicated in a corresponding User Alert, as well as within standard governance
We are proud to continue our tradition of supporting all regions, countries and submission types for our valued customers.
If you or a colleague would like to receive these alerts and our monthly newsletter, please click below.