Health Canada eCTD Update

Last month, Health Canada announced an update to the mandatory use of the electronic Common Technical Document (eCTD) format.  As with other agencies and regions, this helps move Health Canada towards a common submission intake process, as well as standardize and improve its business processes and tools. Previously, as of January 2018, New Drug Submission … Continued

Health Canada Revises Rules for eCTD Submissions

Health Canada recently announced revised validation rules for regulatory transactions for electronic Common Technical Document (eCTD) submissions. The revisions are being implemented to provide additional information and clarification for stakeholders who prepare eCTD transactions. The revised rules also build on the information provided in guidance. Starting February 1, 2018, Health Canada will be validating regulatory transactions in eCTD … Continued

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