mdi Consultants
In the future, you will be able to submit applications 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 and You Conference in Silver Spring, MD on 13 June that 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.
A goal of collaboration between HC and the FDA is to better align our regulatory systems, reduce unnecessary duplications and differences, and, to the extent feasible, better leverage resources to help both agencies meet their public health missions within the parameters allowed by prevailing laws and regulations subject to available human and financial resources.
Building on the strong, extensive and long-standing bilateral regulatory cooperation between the agencies, the FDA and HC will explore and develop proposals outlining joint regulatory collaborations in areas of mutual benefit, such as personal care products and pharmaceuticals for human and animal use. These proposals will outline key elements to help facilitate on-going better systemic alignment of regulatory systems, strategies, and practices between HC and FDA. When exploring potential proposals, FDA and HC will:
- Take stock of collaboration and experience gained to date between the FDA and HC;
- Identify mechanisms for possible regulatory alignment and mutual reliance in such areas as product review and inspection of manufacturing facilities, as well as establishing requirements/standards where appropriate;
- Examine enablers and barriers related to implementation and identify options for addressing barriers (e.g. legislative and administrative barriers).
Deliverable Outcome: Implementation of a Common Electronic Submission Gateway, using the current US gateway, that allows industry clients the ability to submit large size electronic documents seamlessly to Health Canada and US FDA with a view toward further catalyzing increased review collaboration between the two regulatory agencies, increased efficiency of sovereign decision making, and improved access to the introduction of medicines for patients in both countries.
? Any questions about “Health Canada to Use US FDA’s Electronic Submission Gateway (ESG)” please email us at [email protected] and ref: ESG Health Canada.