Reactions 1517, p10 - 6 Sep 2014 Faster drug approvals don’t impact drug safety Faster drug approval times do not increase the rate of drug discontinuation for safety reasons, according to the findings of a study published in Canadian Health Policy. This study used data from Health Canada and the EMA to compare drug approval times in Canada and the EU between 2003 and 2012, and the rates of drug discontinuation for safety reasons. Over the 10-year period, 186 new products were approved by Health Canada and 189 were approved by the EMA. Over 10 years, the median time to drug approval was longer in Canada than in the EU (391 days vs 338 days), but the rate of discontinuation of new drugs for safety reasons was 1.6% in both regions. Drug approval time was much longer in Canada than in the EU during the first 5 years (503 days vs 349 days) but the rate of drug discontinuation was similar (2.2% vs 2.1%). During the second 5 years, the median time to approval was reduced to 353 days in Canada, but no drugs were discontinued for safety reasons. "This means that the added drug approval delay in Canada achieved no extra assurance of safety but imposed a cost on Canadian patients who were forced to forego the potential health benefits that could have been gained from earlier access to new drugs," commented the author. Do faster drug approvals increase safety risks? Evidence from Canada and Europe 2003-2012. Canadian Health Policy : 28 Aug 2014. Available from: URL: http:// www.canadianhealthpolicy.com/research/full-text/do-faster-drug-approvals- increase-safety-risks--evidence-from-canada-and- europe-2003-2012.html 803107698 1 Reactions 6 Sep 2014 No. 1517 0114-9954/14/1517-0001/$14.95 Adis © 2014 Springer International Publishing AG. All rights reserved

Faster drug approvals don't impact drug safety

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Reactions 1517, p10 - 6 Sep 2014

Faster drug approvals don’t impactdrug safety

Faster drug approval times do not increase the rate ofdrug discontinuation for safety reasons, according to thefindings of a study published in Canadian Health Policy.

This study used data from Health Canada and theEMA to compare drug approval times in Canada and theEU between 2003 and 2012, and the rates of drugdiscontinuation for safety reasons. Over the 10-yearperiod, 186 new products were approved by HealthCanada and 189 were approved by the EMA.

Over 10 years, the median time to drug approval waslonger in Canada than in the EU (391 days vs 338 days),but the rate of discontinuation of new drugs for safetyreasons was 1.6% in both regions. Drug approval timewas much longer in Canada than in the EU during thefirst 5 years (503 days vs 349 days) but the rate of drugdiscontinuation was similar (2.2% vs 2.1%). During thesecond 5 years, the median time to approval wasreduced to 353 days in Canada, but no drugs werediscontinued for safety reasons.

"This means that the added drug approval delay inCanada achieved no extra assurance of safety butimposed a cost on Canadian patients who were forcedto forego the potential health benefits that could havebeen gained from earlier access to new drugs,"commented the author.Do faster drug approvals increase safety risks? Evidence from Canada and Europe2003-2012. Canadian Health Policy : 28 Aug 2014. Available from: URL: http://www.canadianhealthpolicy.com/research/full-text/do-faster-drug-approvals-increase-safety-risks--evidence-from-canada-and-europe-2003-2012.html 803107698