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Safety monitoring reviews by Health Canada

Safety monitoring reviews by Health Canada

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Published by torontostar
This is a list of 81 drugs currently on the market that were the subject of safety monitoring reviews by Health Canada in 2013. None of the information produced as a result of these reviews will be publicly released because they contain “confidential business information,” according to the federal department. The information, including adverse drug reaction reports and usage data, is provided by manufacturers “with the understanding that this information is proprietary,” a Health Canada spokeswoman said. An additional 47 drugs were reviewed in this same manner but their names do not appear in this list because they have not yet been approved for sale in Canada.
This is a list of 81 drugs currently on the market that were the subject of safety monitoring reviews by Health Canada in 2013. None of the information produced as a result of these reviews will be publicly released because they contain “confidential business information,” according to the federal department. The information, including adverse drug reaction reports and usage data, is provided by manufacturers “with the understanding that this information is proprietary,” a Health Canada spokeswoman said. An additional 47 drugs were reviewed in this same manner but their names do not appear in this list because they have not yet been approved for sale in Canada.

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Published by: torontostar on Apr 02, 2014
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04/25/2014

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From:
 Leslie Meerburg [mailto:leslie.meerburg@hc-sc.gc.ca]
Sent:
 Wednesday, April 02, 2014 11:18 AM
To:
 Zlomislic, Diana
Subject:
 RE: Drug reviews
 
Good morning Diana - here is the response:
 
********
 
Hello Diana,
 
Thank you for your patience on this. Here is the list you are seeking:
 
Could I get a list of the 128 drugs that are part of the regular monitoring activities?
 
To clarify, 128 refers to the number of reviews and not individual products. We have assessed each of the 128 reviews to determine whether the release of the names of the products would compromise our confidentiality commitments. Some of our regular monitoring activity consists of reviewing Risk Management Plans (RMPs) and Periodic Safety Update Reports (PSURs) for drugs that are currently being assessed and so are not yet on the market. Given that these reports are submitted in advance of market authorization, Health Canada cannot release the names of the drugs or active substances involved. The list of marketed products that have had PSURs or RMPs reviewed in the last year can be found below.
 
Both RMPs and PSURs are submitted to Health Canada with the understanding that this information is proprietary to the respective manufacturer and may contain information that may pose issues with confidentiality and competitive position of other drugs.
 
Health Canada will take the steps necessary to begin publishing safety reviews of pharmaceutical drugs transparently to ensure Canadians and medical professionals have the information they need and want.
 
 
Leslie Meerburg A/Senior Media Relations Advisor | Conseillère principale p.i., relations avec les médias Health Canada | Santé Canada (t) 613.948.8471 (e) leslie.meerburg@hc-sc.gc.ca Government of Canada | Gouvernement du Canada
 
From: "Zlomislic, Diana" <dzlomislic@thestar.ca>
 
To: Leslie Meerburg <leslie.meerburg@hc-sc.gc.ca>
 
Date: 2014-04-02 11:16 AM
 
Subject: RE: Drug reviews
 
Hi Leslie,
 
Thank you for the quick response. Unfortunately, it’s not in my files. Would you please try emailing it again?
 
Cheers,
 

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