dc.contributor.author | Taylor, Michael Duncan | |
dc.date.accessioned | 2010-09-16T19:36:15Z | |
dc.date.available | 2010-09-16T19:36:15Z | |
dc.date.issued | 2010-09-16 | |
dc.identifier.uri | http://hdl.handle.net/10222/13085 | |
dc.description.abstract | 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). | en_US |
dc.subject | law | en_US |
dc.subject | regulation | en_US |
dc.subject | drug | en_US |
dc.subject | Food and Drug Act | en_US |
dc.subject | pharmaceutical | en_US |
dc.subject | clinical trial | en_US |
dc.subject | risk | en_US |
dc.subject | progressive licensing | en_US |
dc.subject | clinical trial | en_US |
dc.subject | C-51 | en_US |
dc.subject | new drug | en_US |
dc.title | A BITTER PILL TO SWALLOW: CANADIAN DRUG REGULATION | en_US |
dc.date.defence | 2010-08-30 | |
dc.contributor.department | Faculty of Law | en_US |
dc.contributor.degree | Master of Laws | en_US |
dc.contributor.external-examiner | William Layhey | en_US |
dc.contributor.graduate-coordinator | Richard Devlin | en_US |
dc.contributor.thesis-reader | Jocelyn Downie | en_US |
dc.contributor.thesis-reader | Michael Hadskis | en_US |
dc.contributor.thesis-supervisor | Jocelyn Downie | en_US |
dc.contributor.ethics-approval | Not Applicable | en_US |
dc.contributor.manuscripts | Not Applicable | en_US |
dc.contributor.copyright-release | Not Applicable | en_US |