Drug Review in Canada: A Comparison With Australia, Sweden, the United Kingdom, and the United States
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DRUG REVIEW IN CANADA: A COMPARISON WITH AUSTRALIA, SWEDEN, THE UNITED KINGDOM, AND THE UNITED STATES* NIGELS. B. RAWSON, PHD Merck FrosstlMRC Professor of Pharmacoepidemiology. College of Pharmacy and Nutrition, University of Saskatchewan, Saskatoon, Saskatchewan, Canada
KENNETHI. KAITIN, PHD Associate Director, Center for the Study of Drug Development. Tufts University, Boston, Massachusetts, United States
KATE E. THOMAS, MSc Research Associate, Centre for Medicines Research International, Carshalton, Surrey, England
GRANTPERRY,BPA Director of Federal Government Relations and Regulatory Affairs, Pharmaceutical Manufacturers Association of Canada, Ottawa, Ontario, Canada
To evaluate the timeliness of the Canadian drug review process, data on approval times of nonbiologic new chemical entities approved between 1992 and 1995 were obtained for Cannda, Australia, and Swedenfrom their national drug regulatory agencies, for the United States from Tufts University’s Center for the Study of Drug Development, and for the United Kingdom from the Centre for Medicines Research International. The information was augmented by a survey of companies performed by the Pharmaceutical Manufacturers Association of C a d . The overall Canadian median approval time (917 days) was significantly longer ( p < 0.001) than those of all the other countries: Australia (620). Sweden (368), the United Kingdom (542), and the United States (623). On a yearly basis, approval times in C a d were significantly longer in 1992-1994, but the median time improved in 1995 to 650 days, which was not significantly different from any of the other countries (562, 444,439, and 464 days, respectively). Further work is required, however: to achieve established review time performance targets and to reduce approval times in all therapeutic classes.
Key Work: Drug approval; Canada; United States; United Kingdom; Australia; Sweden
INTRODUCTION THE TIMELINESS WITH which regulatory agencies approve new drugs for marketing
impacts on the pharmaceutical industry, health professionals, and patients. A long approval process delays the sale of a product which adversely affects the manufacturer’s
Reprint address: Dr. Nigel S. B. Rawson. Division of Community Health, Health Sciences Centre, Memorial University of Newfoundland, St John’s, NF AIB 3V6, Canada. *The opinions and conclusions expressed in this article are those of the authors and do not necessarily represent those of the agencies and organizations supplying data, the respective governments, or the Pharmaceutical Manufacturers Association of Canada. Downloaded from dij.sagepub.com at Purdue University on June 5, 2016
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N. S. B. Rawson, K. I. Kaitin, K. E. Thomas. and G. Perry
income. Much more importantly, however, it limits the access of patients and health professionals to drugs that may improve health status. A significant difference between marketing approval dates in the United Sta
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