+91 6359 596 967

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.

Stakeholders are encouraged to use a commercially available tool to validate their regulatory transactions in “non-eCTD electronic-only” format, prior to filing 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 non-eCTD format using version 4.4 of the “non-eCTD electronic-only” validation rules.

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

For more details please reach us at