eCTD 4.0
eCTD 4.0 shifts regulatory submissions from document management to structured data. Controlled vocabularies are now a validation requirement, not a formatting preference — and each authority manages its own code lists on its own release cycle.
The shift from eCTD 3.2.2 to 4.0 is not just a structural update — it introduces a fundamentally different data model. Submissions must carry validated, structured metadata drawn from authority-published code lists. Where 3.2.2 tolerated free text in many fields, 4.0 enforces vocabulary compliance at validation time.
Metadata validation
CV codes must match authority-published lists exactly. Mismatches trigger submission rejection.
Authority-specific lists
EMA, FDA, Swissmedic and others each publish and version their own code lists independently.
Ongoing alignment burden
Code lists update on different cycles. Keeping internal systems aligned requires active monitoring.
Authority-published code lists ingested from public sources and updated as new versions are released. Click any card to explore the full term list for that CV type.
Reference data last updated: 2026-08-30
Authorities
4
CV types
27
Total terms
1755
Manufactured Product
Context of Use
Document type
Study Keyword
Submission Type
Product Category
Territorial Authority Role
Territory
Language
Application Type
Party type
Regulatory Status
Keywords
Submission Unit Type
US Form type
Procedure Type
Route of Admin
Keyword Definition
Media Type
Mode
Data Classification
Application Reference Reason
Category Event
Not yet populatedIngredient Role
Not yet populatedPlace
Not yet populatedRegulatory Review Time
Not yet populatedSubstance
Not yet populatedThe public lookup above shows what is published. The secure portal lets you work with it — cross-authority comparisons, term-level diff between versions, and AI-assisted mapping between HA code lists and your internal Reg App vocabularies.