ECTD-EMA

EMA electronic drug submission format.

Definition

EMA eCTD uses specific EU Module 1 v3.1 (expert CVs, EU regulatory info). Submission via EMA gateway (CESP, Common European Submission Platform) or eSubmission Gateway. Centralised (CP), Decentralised (DCP), Mutual Recognition (MRP) procedures. Migration to eCTD v4.0 (FHIR-based) planned 2027.

Origin

EMA eCTD mandatory 1 January 2010 for CP ; EU Module 1 v3.1 published 2022.

Example in context

Sanofi submits a Type II Variation to EMA in eCTD via CESP ; EU Commission response in 90 days for SmPC change.

Related terms

• eCTD FDA — US twin.