EMA Publishes eCTD v4 Validation Criteria

The European Medicines Agency (EMA) eCTD team, along with the EU eCTD v4 Subject Matter Experts, has published the first draft of the EU eCTD v4 validation criteria. This document integrates existing rules from eCTD version 3.2.2, modified as necessary to align with the new eCTD v4 standards, and introduces additional rules based on the eCTD v4 specification, particularly regarding schema requirements, including mandatory elements and attributes.

This initial version focuses on centrally authorized products (CAPs) and will be further developed to include rules applicable to mutual recognition procedures (MRPs), decentralized procedures (DCPs), and national authorizations (NAPs).

The optional use of eCTD v4 for CAPs is anticipated for late Q4 2025. The actual timeline for optional use and the start date will depend on the results of the ongoing eCTD v4 technical pilot, with further communications expected in Q4 2025.

For any inquiries, suggestions, or concerns regarding the validation criteria, please contact the EMA at ectd4consultation@ema.europa.eu. The EMA team, along with the EU eCTD v4 Subject Matter Experts, will review and consider all submissions for inclusion in future updates of the validation criteria. 

Please find the complete document on EMA's eSubmission Page.