eCTD: structure, lifecycle, and controlled vocabularies

What eCTD 4.0 changes

eCTD 4.0 moves the regulatory submission standard from document-centric to data-centric. Submissions must carry structured metadata that is validated against authority-controlled code lists — not just formatted text in a defined file structure.

• Stricter metadata requirements — controlled vocabulary codes must match authority-published lists exactly.
• Validation at submission time — rejected submissions are increasingly common where CV codes are stale or mismatched.
• Multiple authority implementations — EMA, FDA, Swissmedic and others each manage their own code lists on different release cycles.

View eCTD controlled vocabularies

This section of the site provides you with a lookup tool for exploring eCTD controlled vocabularies across different health authorities. This is based on the eCTD CV data we have ingested from public sources, and is updated periodically as new versions of the code lists are released by the authorities.

Choose an Agency and code list type to explore terms published by that authority.

Reference data last updated: 2026-01-15.

Agency Choose… FDA ICH EMA SwissMedic Japan

HA Code list type Choose… EU Application Legal Basis EU Application Reference Reason EU Application Submission Type EU Contact Party Role EU Context of Use EU CoU Keyword Definition Type EU Data Classification EU Document type EU Language Code EU Manufactured Product Form EU PI Document Type EU Procedure Type EU Product Category Code EU Submission Mode EU Submission Unit Type EU Territorial Authority EU Territorial Country Code ICH Context of Use ICH Context of Use Status ICH Document Type ICH Duration ICH Keyword Definition Type ICH Route of Administration for Non-Clinical Study ICH Species for Non-Clinical Study ICH Study Group Order Type ICH Type of Control ICH XML Types US Application Type US Context of Use US CoU Keyword Definition Type US Form Type US Promotional Document Type US Promotional Material Audience Type US Promotional Material Type US Submission Contact Status US Submission Contact Type US Submission Type US Submission Unit Status US Submission Unit Type US Telecom Use

Search

Select an agency and code list type, then click Search.

Explore in the secure portal

Harmonising the controlled vocabualries in your "Regulatory Information Management" systems and your eCTD 4 publication systems in line with the controlled vocabulary requirements of the authorities is a critical part of eCTD 4.0 readiness. The public lookup tool above is a starting point, but the secure portal provides deeper access to HA CV data, cross-agency comparisons, and AI-assisted term mapping between HA code lists and internal Reg App vocabularies. Access to the secure portal is not yet enabled. Access process will be published soon.

Related topics

• IDMP overview
• Controlled vocabularies
• Browse HA CVs (secure)
• CV Mapping tool

Key authorities publishing eCTD CVs

• EMA — SPOR / NCA code lists
• FDA — SPL controlled terminology
• Swissmedic — eCTD 4.0 local lists
• Health Canada — structured submission terms
• PMDA — Japanese regulatory CVs

Each authority publishes on a different release cycle, creating an ongoing alignment burden for pharma regulatory teams.