Health Canada

Health Canada

January 31, 2014 16:30 ET

Electronic Health Product Submissions Gateway Comes to Canada

Regulatory Cooperation Delivers Improvements for Industry

OTTAWA, ONTARIO--(Marketwired - Jan. 31, 2014) - Health Canada

Minister of Health Rona Ambrose today announced the launch of the Common Electronic Submissions Gateway (CESG) making it possible for companies to begin sending drug authorization data to Health Canada online using a special dedicated channel of the United States Food and Drug Administration's (US FDA) existing system.

The Gateway will make it faster and easier for companies to submit their information securely to each of the regulators for independent review - reducing the administrative burden on industry and supporting prompt access to safe and effective medications for Canadians.

Through shared responsibilities under the Canada-US Regulatory Cooperation Council (RCC), Health Canada was able to leverage existing technology developed by the US FDA to create an ongoing shared mechanism - reducing the developmental costs to the Government of Canada while also achieving a streamlined approach for Canadian and US industry.

Quick Facts

  • Until now, drug authorization packages have been sent to Health Canada via courier - either in hard copy format or on CD/DVD storage devices.
  • The Gateway uses advanced security technology to ensure the safe online delivery of confidential business data for a range of regulatory transactions.
  • The CESG is another example of the successful work of the RCC to better align regulatory systems between Canada and the United States.

Quotes

"By streamlining the process to allow industry to submit information in an easy and secure manner, Canadians will benefit from faster access to safe and effective medications. This will encourage more companies to bring their products to Canada."

Rona Ambrose
Minister of Health

Related Products

Health Canada - Common Electronic Submissions Gateway

Associated Links

FDA's Blog about the Common Gateway

CESG Work Plan

Health Canada news releases are available on the Internet at: www.healthcanada.gc.ca/media

Contact Information

  • Michael Bolkenius
    Office of the Honourable Rona Ambrose
    Federal Minister of Health
    (613) 957-0200

    Health Canada
    Media Relations
    (613) 957-2983

    Public Inquiries:
    (613) 957-2991
    1-866 225-0709