Articles tagged with “health-canada”

eCTD Software: A Guide to FDA, EMA & Health Canada Rules

Learn the technical requirements for eCTD software submissions to the FDA, EMA, and Health Canada. This guide covers validation rules, mandates, and eCTD v4.0.

40 min read

1/12/2026

ectd software regulatory submissions fda ema health canada ectd v4.0 regulatory affairs common technical document ectd publishing