New validation criteria for eCTD submissions - mandatory since 1st March 2025
As of 1st March 2025 new validation criteria for eCTD submissions are mandatory.
The transition period was from December 2024 till the end of February 2025.
As of 1st March 2025 it is mandatory to submit all electronic submissions in the eCTD format using the new validation criteria of version 8.0.
For further information please check the following EMA website:
https://esubmission.ema.europa.eu/ectd/