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

Sr#
Country
M1 Spec
DTD
Validation Criteria
Current Update

1.

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’,
12

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