• Regul. Toxicol. Pharmacol. · Jul 2018

    Canadian, European and United States new drug approval times now relatively similar.

    • Rawson Nigel S B NSB Eastlake Research Group, Oakville, Ontario, Canada; Canadian Health Policy Institute, Toronto, Ontario, Canada; Fraser Institute, Vancouver, British .
    • Eastlake Research Group, Oakville, Ontario, Canada; Canadian Health Policy Institute, Toronto, Ontario, Canada; Fraser Institute, Vancouver, British Columbia, Canada. Electronic address: EastlakeRG@gmail.com.
    • Regul. Toxicol. Pharmacol. 2018 Jul 1; 96: 121-126.

    AbstractThe objectives of this analysis were to assess whether consistency in Health Canada's (HC's) approval times identified in 2011 has been sustained and to compare HC's approval times with those of the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA). Between 2002 and 2016, 460 new drugs were approved by at least one of the agencies: 351 (76.3%), 319 (69.3%) and 392 (85.2%) by HC, the EMA and the FDA, respectively - all three approved 252 (54.8%). Overall medians and inter-quartile ranges of approval times for HC, the EMA and the FDA were 364 days (343-651), 371 days (322-434) and 304 days (209-455), respectively. The EMA's annual median approval time was consistent over the 15 years, while HC's and the FDA's median times were only consistent with each other and the EMA after 2005. Almost 80% of the drugs approved by all three agencies were submitted to HC later than to the other two agencies, which led to a median delay of a year between the agency first giving approval (FDA or EMA) and HC's approval. Rates of drugs withdrawn for safety reasons were 1.4% in Canada, 0.9% in Europe and 0.8% in the United States.Copyright © 2018 Elsevier Inc. All rights reserved.

      Pubmed     Full text   Copy Citation     Plaintext  

      Add institutional full text...

    Notes

     
    Knowledge, pearl, summary or comment to share?
    300 characters remaining
    help        
    You can also include formatting, links, images and footnotes in your notes
    • Simple formatting can be added to notes, such as *italics*, _underline_ or **bold**.
    • Superscript can be denoted by <sup>text</sup> and subscript <sub>text</sub>.
    • Numbered or bulleted lists can be created using either numbered lines 1. 2. 3., hyphens - or asterisks *.
    • Links can be included with: [my link to pubmed](http://pubmed.com)
    • Images can be included with: ![alt text](https://bestmedicaljournal.com/study_graph.jpg "Image Title Text")
    • For footnotes use [^1](This is a footnote.) inline.
    • Or use an inline reference [^1] to refer to a longer footnote elseweher in the document [^1]: This is a long footnote..

    hide…