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Dalhousie University

1. Taylor, Michael Duncan. A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION.

Degree: Master of Laws, Faculty of Law, 2010, Dalhousie University

This thesis assesses the current status of Canadian prescription drug regulation and the policy drivers that guide this process. This analysis is accomplished by first providing a general survey of the steps, law, and institutional players involved in the full life-cycle of a drug. Next the evolution of current clinical trials and the gaps that the present legal regime creates in the scientific standards employed in clinical research is reviewed. This is followed by a discussion of how commercialization (innovation) and speed of approval (market access) are slowly becoming the dominant policy drivers for the Canadian regime. Finally a discussion of the proposed Progressive Licensing model, and Bill C-51-An Act to Amend the Food and Drug Act, raises the concerns with a shift to a system largely based on risk assessment and post-market monitoring (pharmacovigilence). Advisors/Committee Members: William Layhey (external-examiner), Richard Devlin (graduate-coordinator), Jocelyn Downie (thesis-reader), Michael Hadskis (thesis-reader), Jocelyn Downie (thesis-supervisor), Not Applicable (ethics-approval), Not Applicable (manuscripts), Not Applicable (copyright-release).

Subjects/Keywords: law; regulation; drug; Food and Drug Act; pharmaceutical; clinical trial; risk; progressive licensing; clinical trial; C-51; new drug

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APA · Chicago · MLA · Vancouver · CSE | Export to Zotero / EndNote / Reference Manager

APA (6th Edition):

Taylor, M. D. (2010). A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION. (Masters Thesis). Dalhousie University. Retrieved from http://hdl.handle.net/10222/13085

Chicago Manual of Style (16th Edition):

Taylor, Michael Duncan. “A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION.” 2010. Masters Thesis, Dalhousie University. Accessed October 21, 2019. http://hdl.handle.net/10222/13085.

MLA Handbook (7th Edition):

Taylor, Michael Duncan. “A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION.” 2010. Web. 21 Oct 2019.

Vancouver:

Taylor MD. A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION. [Internet] [Masters thesis]. Dalhousie University; 2010. [cited 2019 Oct 21]. Available from: http://hdl.handle.net/10222/13085.

Council of Science Editors:

Taylor MD. A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION. [Masters Thesis]. Dalhousie University; 2010. Available from: http://hdl.handle.net/10222/13085

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