Health Canada drug approval process slower than in Europe and US
A new report from the Fraser Institute shows that it takes Health Canada nearly a year to grant marketing approval to prescription drugs. According to the report, entitled Federal Delays in Approving New Medicines 2013, Health Canada took a median of 355 days to issue a Notice of Compliance certifying new patented medicines as safe and effective in 2011. According to the Fraser Institute, medicines are often approved faster in Europe and the United States.
In 2010, Health Canada approval was 448 days compared with 319 at the European Medicines Agency. Health Canada also took longer to approve new medicines than did the US Food and Drug Administration (FDA) in 4 out of 5 years from 2007 to 2011. The largest gap was in 2010, when Health Canada approval was 448 days compared with 299 at the FDA.
The report suggests that Canada’s federal government could improve access to new medicines through harmonization and mutual recognition with international regulatory agencies.
The report can be viewed at www.fraserinstitute.org/research-news/display.aspx?id=19592.
. Health Canada drug approval process slower than in Europe and US. BCMJ, Vol. 55, No. 5, June, 2013, Page(s) 234-235 - News.
Above is the information needed to cite this article in your paper or presentation. The International Committee
of Medical Journal Editors (ICMJE) recommends the following citation style, which is the now nearly universally
accepted citation style for scientific papers:
Halpern SD, Ubel PA, Caplan AL, Marion DW, Palmer AM, Schiding JK, et al. Solid-organ transplantation in HIV-infected patients. N Engl J Med. 2002;347:284-7.
About the ICMJE and citation styles
The ICMJE is small group of editors of general medical journals who first met informally in Vancouver, British Columbia, in 1978 to establish guidelines for the format of manuscripts submitted to their journals. The group became known as the Vancouver Group. Its requirements for manuscripts, including formats for bibliographic references developed by the U.S. National Library of Medicine (NLM), were first published in 1979. The Vancouver Group expanded and evolved into the International Committee of Medical Journal Editors (ICMJE), which meets annually. The ICMJE created the Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals to help authors and editors create and distribute accurate, clear, easily accessible reports of biomedical studies.
An alternate version of ICMJE style is to additionally list the month an issue number, but since most journals use continuous pagination, the shorter form provides sufficient information to locate the reference. The NLM now lists all authors.
BCMJ standard citation style is a slight modification of the ICMJE/NLM style, as follows:
- Only the first three authors are listed, followed by "et al."
- There is no period after the journal name.
- Page numbers are not abbreviated.
For more information on the ICMJE Recommendations for the Conduct, Reporting, Editing, and Publication of Scholarly Work in Medical Journals, visit www.icmje.org