Articles tagged with “submission-specification”

A Guide to the ICH M8 eCTD v4.0 Submission Specification

Learn about the ICH M8 eCTD v4.0 submission specification. This guide covers its technical basis in HL7 RPS, file requirements, and global adoption timelines.

40 min read

1/15/2026

ich m8 ectd v4.0 hl7 rps regulatory submissions submission specification regulatory affairs ectd pharmaceutical regulation