Current eCTD Implementation Status

World-wide Health Authorities continuously updating requirements and standards for electronic submission, so it much necessary to keep updated your self with current specifications to make eCTD submission 100% error free and compliant.

Current eCTD Module 1 Specification, DTD, and Validation Criteria Version with Update

M1 Spec
Validation Criteria
Current Update



Health Canada Updated Specifications for eCTD Validation Criteria V4.4

Since June 2016, Health Canada has been providing the Validation Reports only for regulatory transactions that failed validation.

Sponsors are expected to validate their eCTD regulatory transactions and correct any warning(s) and error(s) before sending them to Health Canada.

Although the Agency updated validation criteria without further notice, as of March 30,

Health Canada Updated Validation rules for non-eCTD electronic-only format (V4.4)

These Validation rules build on the information provided in Preparation of Regulatory Activities in “Non-eCTD Electronic-Only” format guideline.

The revised rules assist stakeholders in the preparation of regulatory transactions in Non-eCTD format.

It is important for sponsors to ensure that the validation rules are followed accurately in order to avoid encountering validation errors.

US FDA Updated eCTD Module 1 Specifications Version 2.4

FDA has updated the guideline for module 1 specifications version from v2.3 to v2.4.

Summary of Changes for Version 2.4

Added eCTD Submission Type ‘REMS Supplement’. The updated sections are listed below:

  1. ‘REMS Supplement’ added in Submission Types and Description of Use Table
  2. ‘REMS Supplement’ added as valid submission type for PAS and CBE-30 in Supplement-Effective-Date-Types and Descriptions of Use Table
  3. ‘REMS Supplement’ added as valid submission type for submission sub-types of ‘application’,