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

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

The revised rules build on the information provided in the Guidance Documents such as Preparation of Drug Regulatory Activities in eCTD Format, Creation of the Canadian Module 1 Backbone (eCTD) and the ICH eCTD Specification (Version 3.2.2).

Team Masuu has qualified and experienced Regulatory Operations professionals who provide end to end eCTD publishing support and services throughout the life-cycle of product

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