The final deadline for adopting the new EU eCTD M1 Specification (v3.1.1) and its corresponding Validation Criteria v8.2 is now just weeks away.

Starting December 1, 2025, all submissions to the European Medicines Agency (EMA) must comply with these new requirements to avoid validation of failure and potential rejection.

As a reminder, here’s what changed:

  • An updated tracking table for EDQM
  • New examples for product and procedure numbers (for work-sharing & super-grouping)
  • The mandatory use of Validation Criteria v8.2 from December 1, 2025

Your Final Compliance Timeline:

  • November 30, 2025: Submissions must use M1 v3.1 or v3.1.1 and can use Validation Criteria v8.1 or v8.2.
  • From December 1, 2025: Only submissions using M1 v3.1.1 and Validation v8.2 will be accepted.

Non-compliance after the deadline will lead to submission rejections and costly project delays. With time running out, our experts can ensure your dossiers are fully compliant without disrupting your timelines.

Consult Now

Source
https://esubmission.ema.europa.eu/index.html
Select Mandate HA
EMA
Select Mandate Function
Publishing & Submissions