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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 format using version “CA eCTD – Profile 4.3.” Sponsors will be expected to validate their eCTD regulatory transactions and correct any warning(s) and error(s) before sending them to Health Canada.

For more details, please see Health Canada’s announcement.

Synchrogenix offers an array of eCTD services and software that are fully supportive of regulatory transactions in eCTD format. Our GlobalSubmit PUBLISH solutions software is being updated to incorporate these revised validation rules. Register today for the next overview of our regulatory publishing services on January 31.

With an office in Montreal, Synchrogenix has a presence in Canada and abroad. We offer a wide array of regulatory strategy, writing, services and solutions to pharmaceutical, device diagnostics, and tobacco companies worldwide. Please contact us at contactus@synchrogenix.com to learn how we can assist your organization.

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