FDA has updated the guideline for Specifications for eCTD Validation Criteria (V3.8). In this version FDA updated;

• Descriptions of the eCTD Validation Criteria of Error Codes 1734, 1735, and 1736 which support the Study Data Technical Conformance Guide

Again, FDA has updated the Providing Regulatory Submissions in Electronic Format guideline. Now, the requirement to submit DMF Type III (Packaging Material) electronically (in eCTD format only) become effective 60 months after May 5, 2015 (May 5, 2020).

For DMF Type III, applicant must electronically submit any amendments, supplements, and reports,

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.

Health Canada has updated the timeline for Mandatory Use of eCTD Format for Types of Regulatory Activity.

From since 2004, Health Canada is accepting regulatory activities in eCTD format. As of December 2018, 93 percent of regulatory activities (Part C, Division 8 of the Food and Drug Regulations, for human drugs) have been submitted in eCTD format.