ECTD-FDA

FDA electronic drug submission format.

Definition

eCTD v3.2.2 structure: Module 1 (regional FDA admin), Module 2 (summaries), Module 3 (Quality), Module 4 (Non-clinical), Module 5 (Clinical). XML backbone + PDF leaves. Submitted via FDA ESG (Electronic Submissions Gateway). ICH M8 migration to eCTD v4.0 (HL7 RPS) planned post-2026.

Origin

ICH eCTD M2 published 2003 ; FDA mandatory NDA/BLA May 2017.

Example in context

Pfizer files its Paxlovid BLA in eCTD via FDA ESG ; ~30000 documents in Module 5 (clinical study reports) plus 200 studies.

Related terms

• eCTD EMA — European twin.