Single XML Submission File

Ectd 4.0 Moves From A Web-Based, Multiple XML File Structure To A Data-Driven
Format With A Single XML Submission File (Submissionunit.Xml). This Reduces
Structural Updates And Software Release Cycles.

Document Lifecycle Management

Ectd 4.0 Enables Easier Document Lifecycle Operations Like Replacing One Document
With Multiple Documents Or Vice Versa Within The Same Group. Each Document Has A
Universally Unique Identifier (UUID) For Referencing Across Submissions

Bi-directional Communication

Unlike Previous One-Way Submission Models, Ectd 4.0 Enables Bi-Directional
Communication Between Sponsors And Regulators, Facilitating Collaboration And

Controlled Vocabularies

Ectd 4.0 Introduces Standardized Terminology And Data Formats Through Controlled
Vocabularies Managed By ICH, Regional Authorities, And Third Parties. This Enhances Consistency And Information Transfer

Flat Submission Structure

The Hierarchical Table Of Contents Is Replaced By A Flat Structure Using Context Of Use Terminology, Keywords, And Sender-Defined Listings To Sort And Display