Validation Rules for Regulatory Transactions Submitted in the electronic Common Technical Document (eCTD) Format

Author: Bhavesh Patel, C. Chem.

Late last year, Health Canada announced the revised validation rules for regulatory transactions in the electronic Common Technical Document (“eCTD”) format.

These revised validation rules can be found at the reference link below to provide further information to stakeholders to assist them in the preparation of regulatory transactions in eCTD format. The revised rules 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 Conference on Harmonisation (ICH) Electronic Common Technical Document Specification (Version 3.2.2).

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) or error(s) before sending submission to Health Canada.

Although the profile may be updated without further notice, as of February 1st, 2018, Health Canada is validating regulatory transactions in eCTD format using version CA eCTD - Profile 4.3

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Reference: 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