eCTD
Electronic Common Technical Document, the standard format for regulatory submission dossiers.
What it means
eCTD (Electronic Common Technical Document) is the international standard format for submitting regulatory information to medicines agencies. It organizes documents into modules covering administrative information, summaries, quality, nonclinical, and clinical data. Many Latin American regulators now accept or require eCTD submissions, and translated documents must fit within the eCTD structure and naming conventions.
Why it matters for LATAM submissions
An eCTD submission is only as good as its weakest file. A translated document that is correct but placed in the wrong module, or named incorrectly, can cause a technical rejection.
Relevant regulators
Related terms
Translating this concept for a submission?
Send one document to Amavita and we'll return it with the correct terminology, certification, and formatting for the regulator you're targeting. No charge, no commitment.
Start your LATAM pilot