Health Canada has updated the validation rules for regulatory transactions submitted in the non-eCTD format. These rules are built in accordance with the information provided in the following documents:
- Guidance Document: Preparation of Regulatory Activities in Non-eCTD format
- Guidance Document: The Regulatory Enrolment Process (REP)
The purpose of the validation rules is to help ensure Sponsors provide a valid electronic transaction to Health Canada, and reduce errors and follow-up with Sponsors. Sponsors are encouraged to use a commercially available tool to validate their regulatory transactions in non-eCTD format, prior to filing them to Health Canada…
