Health Canada revises validation rules for eCTD format

By 28. May 2019Blog

As part of our continuous global regulatory updates and in case it did not catch your attention, please be reminded on the Health Canada revised validation rules for regulatory transactions in the electronic Common technical Document (eCTD) format, which are applicable since March 30th, 2019.

These revised validation rules (https://www.canada.ca/en/health-canada/) are being posted to provide further information to stakeholders to assist them in the preparation of regulatory transactions in eCTD format. The revised rules also build on the information provided in the Guidance Document: Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format as well as specifications for the regional administrative module (Module1) of the eCTD standard defined in Guidance for Industry: Creation of the Canadian Module 1 Backbone (eCTD) and the International Council for Harmonisation (ICH) Electronic Common Technical Document Specification (Version 3.2.2).

As of March 30, 2019, Health Canada will be validating regulatory transactions in eCTD format using version 4.4 of the eCTD validation rules.

 

Source: https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/applications-submissions/guidance-documents/ectd/notice-validation-rules-regulatory-transactions-submitted-health-canada-electronic-common-technical-document-format-2016-12-1.html