eCTD submission

Common Electronic Submission Gateway (CESG) for Regulatory Transaction at Health Canada for Health Product

In January 2013, CESG is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the USFDA, to reduce regulatory burden for health products as part of the Canada-U.S. If you are already registered with the FDA as a Trading Partner and now wish to do business with Health Canada via the CESG, you do not need to create a new account. You can use your existing account and simply select “HC” as the Review Centre.


http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/cesg-pcde/index-eng.php

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