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Here is a link to information on the Canadian Inte

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Post# of 154821
(Total Views: 832)
Posted On: 03/06/2021 11:14:10 PM
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Posted By: ClosetInvestor
Here is a link to information on the Canadian Interim Order (IO). If Canada provides approval soon, approval would likely fall under IO implication section titled, “Drugs not authorized in Canada or by a foreign regulatory authority.” Summary below.

“The Interim Order introduces an expedited pathway for the authorization of a new COVID-19 drug by providing more agile application and administrative requirements than what is offered under division 8 of the Food and Drug Regulations.

Instead of providing detailed reports of the tests establishing the safety of a new drug and substantial evidence of clinical effectiveness as required by the Food and Drug Regulations, the Interim Order requires an applicant to submit the known information with respect to the safety and effectiveness of a COVID-19 drug.

In addition, in order to expedite the review process for drug applications submitted for authorization under the Interim Order, a more agile approach has been included to allow an applicant to file further information throughout the course of the review as it becomes available, also known as a rolling application. If using this rolling application approach, the applicant must submit a plan outlining how and when they will provide the Minister with the required information or data that is outstanding.”

https://www.canada.ca/en/health-canada/servic....html#a4.1

Here is a list of drugs approved for COVID19 in Canada. 6 of the 7 drugs were approved under the IO.

https://www.canada.ca/en/health-canada/servic...drugs.html


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