eCTD submission

CESG for Regulatory Transaction at Health Canada for Medicinal Product

In January 2014, CESG (Common Electronic Submission Gateway) is part of ESG for regulatory submission of medicinal product to Canada means Health Canada is participating with the US FDA, 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 Center.

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

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