Instructions and Benefits of the Common Electronic Submissions Gateway (CESG)
How to use the Common Electronic Submissions Gateway (CESG) to send regulatory transactions to Health Canada
In order to begin using the CESG each sponsor must first complete the following steps:
Step 1: Register as a Trading Partner with Food & Drug Administration (FDA)
- Complete the FDA Electronic Submissions Gateway (ESG) registration for a WebTrader or AS2 account in order to be able to send your regulatory transaction.
- For more information on how to register as a Trading Partner with the FDA please see the FDA User Guide.
Step 2: Send regulatory transactions to Health Canada via the CESG
- Send regulatory transactions to the FDA ESG and ensure that "HC" is selected as the centre.
- Regulatory transactions intended for Health Canada will be automatically redirected.
- For more information on how to submit regulatory transactions please see the FDA User Guide.
- Contact us for any questions or technical difficulties. Please refer to Inquiries and Support for details on where to direct your questions.
Benefits of the Common Electronic Submissions Gateway (CESG) for regulatory transactions in electronic Common Technical Document (eCTD) format
The electronic Common Technical Document (eCTD) is an international harmonized technical standard developed by the International Conference on Harmonisation (ICH) and covers the exchange of CTD data in electronic format. The standard establishes the messaging requirements (such as the interface) for the electronic exchange of regulatory information between a Trading Partner (for example, the pharmaceutical industry) and a regulator.
The CESG supports the use of the eCTD format by providing 2 additional means of transmission: a Gateway-to-Gateway interface (AS2) and a web interface (WebTrader).
Benefits to sending regulatory transactions via the CESG include:
- Trading Partners have the ability to seamlessly provide electronic transactions to both Health Canada and the Food and Drug Administration (FDA), making it logistically simpler and less time consuming
- Decreased courier costs from no longer mailing CDs or shipping boxes of binders
- CESG stimulates use of eCTD which results in less paper generated in the transmission and review of a regulatory transaction
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