The EMA has published the latest EU Module 1 specification (v3.1.1) together with Validation Criteria v8.2, marking an important step towards harmonisation and improved regulatory submission processes.
What’s new in v3.1.1 / v8.2?
- Introduction of “super-grouping” with clearer guidance and worked examples, especially for worksharing procedures
- New examples provided for the pre-submission phase product number
- An exception included in the validation criteria that tracking tables are not required for EDQM
Implementation timeline:
1 Oct – 30 Nov 2025: Transition phase – both v3.1/v8.1 and v3.1.1/v8.2 accepted.
From 1 Dec 2025: Only v3.1.1 & v8.2 submissions will be valid.
So now is the time to act; ensure your publishing tools and processes are updated before December 1st to remain compliant with the EU regulatory requirements.
Could your organisation benefit from Starodub’s extensive eCTD support and knowledge? Don’t hesitate to reach out via [email protected] to find out!
