The EMA eCTD team and the EU eCTD v4.0 Subject Matter Experts are pleased to announce that a draft EU eCTD v4.0 validation criteria is now available here. The list is a combination of rules existing in eCTD 3.2.2 (adapted to the new standard, where necessary), and new rules, extracted from the eCTD v4.0 specification, mainly related to the schema (for example mandatory elements and attributes). The EU eCTD v4.0 validation criteria complements the latest eCTD v4.0 ICH validation criteria.
The list is focused on the centrally authorised products (CAPs) and will be further edited to contain rules for MRPs, DCPs and NAPs
The eCTD tool vendors are encouraged to start implementing the rules, in preparation for the optional use of eCTD v4.0 for CAPs, planned for late Q4 2025. The scope of the optional use and the actual start date depend on the results of the ongoing eCTD v4.0 technical pilot, and will be communicated in Q4.
For any concerns, recommendations or questions, please send an email to ectd4consultation@ema.europa.eu. The EMA team, together with the EU eCTD v4.0 Subject Matter Experts, will centralise and analyse the requests, and if considered valid, will include them in the following version of the validation criteria.