Health Canada (HC) announced the revision of the validation rules for Regulatory transactions in electronic Common Technical Document (eCTD) format and published them as Version 4.4 on March 6, 2019. The Agency reported that the latest version of the rules, meant to educate the stakeholders in preparation and submission of Regulatory transactions in eCTD format, will be effective from March 30, 2019.

The revised validation rules are built on the information provided in the below-listed guidance documents:

  • Preparation of Drug Regulatory Activities in eCTD Format
  • Creation of the Canadian Module 1 Backbone (eCTD) - Specifications for the regional administrative module (Module1) of the eCTD standard
  • International Council for Harmonisation (ICH) Specification (Version 3.2.2)

To align with HC’s regulations, applicants must validate their eCTD Regulatory transactions in comparison with the rules provided in the guidance document and rectify any error(s) before submitting them to the HC. In spite of the fact that there might be an update to the profile as of March 30, 2019, Health Canada will be reviewing the Regulatory transactions referring to the 4.4 version of the validation rules. So, the sponsors / stakeholders must keep track of revisions and decode latest of the rules to remain complaint while submitting any Regulatory transactions in eCTD format to the Health Canada.

How are you aligned with the latest validation rules? Be informed to be compliant.


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