EMA Releases eCTD v4.0 CV v2 – New Entries and Updates Explained

In August 2025, EMA released version 2 of the EU eCTD v4.0 Controlled Vocabularies in .xlsx format—introducing new guidance for paediatric applications, ISO‑IDMP standards for PMS, and the new Object Identifier (OID) for the upcoming EU Module 1 Implementation Guide v1.3. A genericode (.xml) version will follow soon. Regulatory teams should update their processes now to stay ready for eCTD v4.0 adoption later this year.

EMA Releases EU eCTD v4.0 Controlled Vocabularies v2

In August 2025, the European Medicines Agency (EMA) published version 2 of the EU eCTD v4.0 Controlled Vocabularies (CVs) in .xlsx format. The update includes a small number of changes, clearly marked as new or updated, and introduces the OID for the upcoming EU Module 1 Implementation Guide v1.3. The genericode (.xml) counterpart will be released soon after.

What’s New and Updated?

EMA highlights the following new entries:

• Procedural Advice on Paediatric Applications – Tailored guidance and forms for paediatric submissions.
• Product Management Service (PMS) – ISO‑IDMP – Standards for medicinal product identification aligned with ISO‑IDMP.

And the updated entries:

• Controlled Vocabularies v2 (.xlsx) – Updated document with changes clearly marked as new or updated.
• OID for EU Module 1 IG v1.3 – Marks the next Implementation Guide version, preparing for its release.

These updates strengthen structured metadata and align submissions with the latest EMA expectations.

Why eCTD v4.0 Controlled Vocabularies V2 Matters

This release supports regulatory consistency by integrating paediatric guidance and ISO‑IDMP classifications. MAHs and CROs should update their systems to prevent validation issues and prepare for the upcoming eCTD v4.0 adoption.

Recommended Next Steps

1. Download CV v2 (.xlsx) from the EMA eSubmission portal and review all new/updated entries.
2. Apply the new OID (IG v1.3) in submission metadata once the updated Implementation Guide is released.
3. Watch for the genericode (.xml) version to streamline system integration.
4. Update internal SOPs, documentation, and training to include the new paediatric and ISO‑IDMP elements.
5. Test processes ahead of optional use of eCTD v4.0 for centrally authorised products (CAPs) later this year.
   
   

These updates might look small on paper, but they make a real difference in daily regulatory work. By reviewing the new and updated entries now, you can ensure your submissions are accurate, compliant, and ready for eCTD v4.0. Getting ahead with the new OID for Module 1 IG v1.3 and preparing for the upcoming genericode (.xml) version means fewer surprises, smoother validations, and a stronger foundation for future submissions.

Taking the time to integrate these changes today helps your team work smarter, stay aligned with EMA standards, and feel confident when the next wave of eCTD submissions arrives.