Health Canada to Use US FDA’s Electronic Submission Gateway (ESG) for eCTD Submissions

Very soon Pharmaceutical organization able to submit/transfer their eCTD Submissions to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the health product review process.

One initiative in this collaboration is the U.S. Food and Drug Administration’s (FDA) – Health Canada Common Electronic Submission Gateway project, will enable industry to submit health product submissions online for approval to Health Canada, in the same way they do in the U.S.

Michael Fauntleroy, Program Manager of FDA’s Electronic Submissions Gateway, noted during a presentation for the GDUFA Conference in Silver Spring, MD on 13^th June 2013 that the FDA and Health Canada are in negotiations for FDA to act as a service provider to Health Canada to facilitate electronic submissions via the ESG. Mr. Fauntleroy hoped that the production environment would be available this fall.

Find link to a summary of the plan and goals from a Canadian government website.

http://actionplan.gc.ca/en/page/rcc-ccr/common-electronic-submissions-gateway-esg-work-plan