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The timeliness of new drug approvals in Canada.
Int J Health Serv. 1995; 25(1):153-65; discussion 167-71.IJ

Abstract

In a recent article, Lexchin asks "who needs faster drug approval times in Canada?" and, on the basis of extremely limited and selective data, draws the conclusion that neither the public nor the pharmaceutical industry does. Whether the Canadian system is really slower is investigated by comparing Canadian and U.S. marketing approval dates and by using information on regulatory approval times from the two countries and elsewhere. Marketing approval dates in Canada are significantly later than those in the United States, although not consistently across all therapeutic categories; anti-cancer and gastrointestinal drugs have earlier approval dates in Canada. However, Canadian and U.S. regulatory approval times are not significantly different, indicating that marketing applications are submitted later in Canada, but both are considerably longer than those in the United Kingdom. The evidence shows that Canadians need faster drug approval times if individuals requiring the medications are not to suffer unnecessarily. A significant decrease in drug approval times and the establishment of comprehensive and effective postmarketing surveillance would reduce the time it takes for new drugs to be made available to Canadians while, at the same time, providing a high level of drug safety.

Authors+Show Affiliations

Royal University Hospital, Saskatoon, Saskatchewan, Canada.

Pub Type(s)

Comment
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

7794387

Citation

Rawson, N S.. "The Timeliness of New Drug Approvals in Canada." International Journal of Health Services : Planning, Administration, Evaluation, vol. 25, no. 1, 1995, pp. 153-65; discussion 167-71.
Rawson NS. The timeliness of new drug approvals in Canada. Int J Health Serv. 1995;25(1):153-65; discussion 167-71.
Rawson, N. S. (1995). The timeliness of new drug approvals in Canada. International Journal of Health Services : Planning, Administration, Evaluation, 25(1), 153-65; discussion 167-71.
Rawson NS. The Timeliness of New Drug Approvals in Canada. Int J Health Serv. 1995;25(1):153-65; discussion 167-71. PubMed PMID: 7794387.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - The timeliness of new drug approvals in Canada. A1 - Rawson,N S, PY - 1995/1/1/pubmed PY - 1995/1/1/medline PY - 1995/1/1/entrez SP - 153-65; discussion 167-71 JF - International journal of health services : planning, administration, evaluation JO - Int J Health Serv VL - 25 IS - 1 N2 - In a recent article, Lexchin asks "who needs faster drug approval times in Canada?" and, on the basis of extremely limited and selective data, draws the conclusion that neither the public nor the pharmaceutical industry does. Whether the Canadian system is really slower is investigated by comparing Canadian and U.S. marketing approval dates and by using information on regulatory approval times from the two countries and elsewhere. Marketing approval dates in Canada are significantly later than those in the United States, although not consistently across all therapeutic categories; anti-cancer and gastrointestinal drugs have earlier approval dates in Canada. However, Canadian and U.S. regulatory approval times are not significantly different, indicating that marketing applications are submitted later in Canada, but both are considerably longer than those in the United Kingdom. The evidence shows that Canadians need faster drug approval times if individuals requiring the medications are not to suffer unnecessarily. A significant decrease in drug approval times and the establishment of comprehensive and effective postmarketing surveillance would reduce the time it takes for new drugs to be made available to Canadians while, at the same time, providing a high level of drug safety. SN - 0020-7314 UR - https://www.unboundmedicine.com/medline/citation/7794387/The_timeliness_of_new_drug_approvals_in_Canada_ L2 - http://journals.sagepub.com/doi/full/10.2190/3XHM-EW8F-5HJY-2D5N?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -