Common Electronic Submissions Gateway

Background

Health Canada is collaborating with its United States regulatory counterpart, the Food & Drug Administration (FDA), to reduce regulatory burden for health products as part of the Canada-U.S. Regulatory Cooperation Council (RCC) Action Plan. The CESG enables Health Canada move closer to fulfilling a shared vision for the Department and Industry to achieve an electronic environment for the exchange, review and management of information supporting the health product review process.

In January 2013, Health Canada and the FDA entered into a Cooperative Research and Development Agreement (CRADA). The CRADA agreement authorizes the Health Products Food Branch (HPFB) and the FDA to collaborate on a joint initiative to deliver an Industry-facing electronic Submissions gateway, beginning with the adaptation and sharing of the FDA's Electronic Submissions Gateway for regulatory drug review processes by Health Canada.

Industry trading partners now have the ability to seamlessly send regulatory transactions electronically to both Health Canada and the FDA, thereby making it easier and less time consuming to initiate the regulatory process. It is important to note that although the CESG can be used to send regulatory transactions to both Health Canada and the FDA, all reviews and approvals are done separately.

Scope

A jointly-planned Common Electronic Submissions Gateway (CESG) pilot between the U.S. FDA and Health Canada was completed in October 2013. A gradual on-boarding phase began in November 2013 with pilot participants using the CESG to provide responses to Requests for Clarification for all types of regulatory activities in eCTD format. This on-boarding phase will be gradually expanded to other selected regulatory transactions and additional Trading Partners through January 2014 and beyond. For a list of regulatory transactions which can currently be sent to Health Canada via CESG please refer to the Frequently Asked Questions.

The following topics and links provide additional information about how to register, connect and submit regulatory transactions using the CESG.