Validation rules for regulatory transactions in electronic Common Technical Document (eCTD) format
Health Canada has updated the validation rules for regulatory transactions submitted in the eCTD format, to reflect recent and upcoming changes in its processes. These rules are built in accordance with the information provided in the following documents:
- Guidance Document – Preparation of Drug Regulatory Activities in Electronic Common Technical Document (eCTD) Format;
- Creation of the Canadian Module 1 Backbone (eCTD) format – Guidance Document
- International Council for Harmonisation (ICH) Electronic Common Technical Document Specification (Version 3.2.2)
- 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 eCTD format, prior to filing them to Health Canada.
- Health Canada validates each regulatory transaction as it is received.
- If the validation fails due to one or more errors detected, an eCTD Validation Report describing each error will be emailed to the sponsor as a.pdf file attachment.
Version of the eCTD validation rules: 5.3 will be effective from 31 May 2025.
Full details of the of the update are available at the link below.
Source: Health Canada
Validation rules for regulatory transactions in non-eCTD format
Health Canada has also 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)
Version of the non-eCTD validation rules: 5.3 will be effective from 31 May 2025.
Full details of the of the update are available at the link below.
Source: Health Canada